Intrastomal corneal ring segments: reversibility of refractive effect

PURPOSE: To evaluate the reversibility of refractive effect following removal of the ICRS (intrastromal corneal ring segments; Intacs). METHODS: Data from 34 eyes from which ICRS were removed during United States FDA Phase II and III clinical trials were evaluated with regard to segment size, loss or change of best spectacle-corrected visual acuity (BSCVA), any change of uncorrected visual acuity (UCVA), manifest spherical equivalent refraction, manifest cylinder refraction, stability of manifest cylinder refraction, and subjective visual symptoms. RESULTS: Out of 725 initial or contralateral eyes placed with the ICRS during Phase II and III clinical trials, segments were removed from 34 eyes (4.7%). Other than one (1/725, 0.1%) safety related ICRS removal, 30/725 (4.1%) were due to visual symptoms. ICRS removal was accomplished under topical anesthesia without complications in all eyes. The mean length of time the segments remained in the cornea after initial surgery was 10.3 +/- 5.4 months. At 3 months after ICRS removal, 21 eyes had monitored data available and were within +/-1 line or 10 letters of their preoperative BSCVA. Twenty eyes (20/21, 95%) returned to within +/-1.00 D of their preoperative manifest spherical equivalent refraction. All eyes had a stable refraction at the 3-month examination after removal, and a manifest spherical equivalent refraction within +/-1.00 D of their 1-month examination after removal. Nineteen eyes (19/21, 90%) returned to within +/-2 lines and 16 eyes (16/21, 76%) returned to within +/-1 line of preoperative UCVA. CONCLUSION: The ICRS (Intacs) was easily and safely removed, and eyes returned to preoperative refractive status within 3 months.     

Correction of astigmatism with short arc-length intrastromal corneal ring segments: preliminary results

OBJECTIVE: To evaluate the refractive effect of 130 degrees short arc length intrastromal corneal ring segments (ICRS) designed to correct myopia concurrent with astigmatism. DESIGN: Prospective, nonrandomized, comparative (self-controlled) trial. PARTICIPANTS: Ten eyes of 6 patients from one surgical center with manifest refraction spherical equivalent between -1.00 and -6.00 diopters (D), manifest cylinder correction between 1.00 and 6.00 D, and best spectacle-corrected visual acuity of 20/20 or better. INTERVENTION: The patients were assigned to receive 1 of 6 ICRS thicknesses, ranging from 0.25 to 0.50 mm by 0.05 mm increments, with an arc length of 130 degrees. MAIN OUTCOME MEASURES: Vector analysis of astigmatic correction. Efficacy was assessed by uncorrected visual acuity and by deviation of postoperative spherical and cylindrical refractive error from predicted correction. Safety was assessed by maintenance or loss of preoperative best spectacle-corrected visual acuity. Measurements were made before surgery and after surgery at days 1 and 7 and months 1, 2, 3, and 6. RESULTS: At 6 months, uncorrected visual acuity was 20/20 or better in 80% of eyes (8/10) and 20/40 or better in all eyes. Eight of 10 eyes (80%) were within +/-0.25 D of plano spherical equivalent manifest refraction. There was no loss of best spectacle-corrected visual acuity, and 6 of 10 eyes (60%) gained a line. Reduction of keratometric cylinder by ICRS thickness was statistically significant (P = 0.039). CONCLUSIONS: Preliminary results of visual and refractive performance after correction of compound myopic astigmatism using short arc length ICRS are promising.     

Reversibility and exchangeability of intrastromal corneal ring segments

PURPOSE: To evaluate the effect of removal and/or exchange of intrastromal corneal ring segments (ICRS, Intacs); specifically the risk factors, degree of reversibility, and visual outcomes. SETTING: Gimbel Eye Centres, Calgary, Edmonton, and Vancouver, Canada. METHODS: Prospective cohort data were collected on 71 eyes that had ICRS placement by 3 surgeons at the Gimbel Eye Centres between August 1998 and July 1999. Data included patient symptoms, best spectacle-corrected visual acuity, uncorrected visual acuity (UCVA), manifest refraction, reason for removal or replacement, keratometry, corneal topography, and complications. RESULTS: Twenty-four eyes (33.8%) had exchange or removal procedures because of underresponse, 20 eyes; overresponse, 2 eyes; and induced astigmatism and shallow placement, 1 eye each. Secondary procedures were removal and replacement, removal with subsequent laser in situ keratomileusis, and segment repositioning. Two risk factors for secondary surgery were identified: high preoperative refractive astigmatism and postoperative spherical equivalent greater than +/-0.5 diopter (D). The 6 eyes that had ICRS removal stabilized to within +/-0.25 D of the original refractive error with no surgically induced astigmatism within 1 to 7 weeks (mean 4 weeks) and had a final UCVA of 20/20 or better. In the 15 eyes that had ICRS exchange procedures, the UCVA improved by at least 1 line and median UCVA improved from 20/40 to 20/20. CONCLUSION: Preliminary data from this study indicate that removal of segments resulted in reversal of the refractive effect.     

Intrastromal corneal ring segments in a patient with previous laser in situ keratomileusis

PURPOSE: Intrastromal corneal ring segments (ICRS; Intacs) were inserted in a patient with residual myopia of -3.375 D (spherical equivalent) 10 months after laser in situ keratomileusis (LASIK). METHODS: A standard intrastromal corneal ring segment implantation technique was used with the addition of intraoperative ultrasonic pachymetry in 4 quadrants at the 7-mm zone to insure adequate stromal thickness for segment insertion. RESULTS: Four months after ICRS surgery and 14 months after LASIK, the patient had uncorrected visual acuity of 20/20 and a cycloplegic refraction of plano -1.00 x 23 degrees. CONCLUSION: Implantation of intrastromal corneal ring segments in an eye with previous LASIK resulted in additional corneal flattening with a decrease in residual myopia and improved uncorrected visual acuity.     

Intrastromal corneal ring implantation for the correction of myopia: 12-month follow-up

PURPOSE: To evaluate the efficacy, predictability, and stability of refraction obtained after intrastromal corneal ring segment (ICRS) implantation for low to moderate myopia. SETTING: Single-center clinical practice. METHODS: In this prospective 2-surgeon study, 9 patients (15 eyes) with low to moderate myopia were recruited to receive ICRS implants. RESULTS: At 1 day, 10 of the 15 eyes had an uncorrected visual acuity (UCVA) of 20/40 or better. At 12 months, all eyes had this UCVA and 66.6% had 20/25 or better. The mean manifest refraction stabilized after the first week at <-0.5 diopter (D). At 12 months, all eyes were within +/-1.0 D of the intended manifest refraction; 67% were within +/-0.5 D. Sixty percent of eyes had no change from the preoperative best corrected visual acuity; 13.3% improved by 1 line, and 26.6% lost 1 line. The postoperative complications included lamellar channel deposits (n = 12), ICRS dislocation (n = 2), corneal infiltrates (n = 2), bleeding in the positioning ring hole (n = 1), 0.3 mm segment decentration (n = 1), and prolonged wound healing (n = 1). CONCLUSIONS: Intrastromal corneal ring segment implantation for the correction of low to moderate myopia afforded good visual recovery and efficacy similar to that with laser in situ keratomileusis and superior to that with photorefractive keratectomy. However, light or blunt trauma and insufficient hygiene can have serious consequences and there is the potential for induced astigmatism. Corneal infiltrates can occur and must be treated immediately. The ring implantation technique is demanding. Advantages of ICRS implantation include rapid and stable visual recovery as well as reversibility.     

Topographic predicted corneal acuity with intrastromal corneal ring segments.

PURPOSE: To evaluate predicted optical quality of the central anterior corneal surface before and after the intrastromal corneal ring segment (ICRS) refractive procedure using a clinical videokeratoscope and software index developed for that purpose. METHODS: Predicted corneal acuity, a topographically derived index provided with the EyeSys System 2000 videokeratscope, representing potential optical quality of the cornea, was assessed preoperatively and at postoperative month 3 in 94 eyes that received an ICRS to treat -1.00 to -6.00 D of myopia. Predicted corneal acuity was calculated by determining the difference between a measured cornea and its best-fit ellipses for reflected ring circumferences within the central 3 mm diameter zone. RESULTS: Preoperative predicted corneal acuity was 20/10 in 92 of 94 eyes (98%). At month 3 after the ICRS procedure, 48 (51%) of moderately myopic eyes were corrected to 20/20 or better, 96% (90 eyes) were corrected to 20/40 or better, and 98% of eyes (92 eyes) had a predicted corneal acuity of 20/10. For the eyes with a predicted corneal acuity of 20/10, spectacle-corrected visual acuity was normally distributed between 20/10 and 20/25. CONCLUSION: Predicted corneal acuity did not change significantly from baseline in eyes with an ICRS. This suggests that topographic irregularities in the central 3 mm of the cornea detectable by predicted corneal acuity software were not induced in the central cornea with the ICRS.     

Characterization of the aspheric corneal surface with intrastromal corneal ring segments.

PURPOSE: Anterior corneal surface asphericity was examined in eyes of Phase II clinical trial participants, before and after intrastromal corneal ring segments (ICRS, Intacs) refractive surgery, and surveyed for relationship to clinical visual performance. METHODS: Aspheric test objects with surface asphericity (Q) ranging from -0.01 Q to -1.44 Q and base radius of curvatures ranging from 7.5 mm to 9.0 mm were measured topographically using videokeratography. Radius of curvature asphericity profile plots were produced for test objects and compared to similar plots created for trial participant eyes (n=25) to quantify corneal asphericity. The potential effects of different amounts of corneal asphericity were assessed using measurement of uncorrected and spectacle-corrected visual acuity and photopic contrast sensitivity. RESULTS: Preoperative corneal asphericity ranged from -0.01 Q to -0.81 Q and postoperative from -0.01 Q to -1.44 Q. Preoperative uncorrected visual acuity was significantly related to corneal asphericity; more myopic eyes tended to have more prolate corneal asphericity. Corneal asphericity was not significantly related to spectacle-corrected visual acuity or photopic contrast sensitivity, before or after surgery. CONCLUSION: Postoperative corneal asphericity values demonstrated that intrastromal corneal ring segments (Intacs) produced a prolate aspheric surface for myopic correction from -1.00 D to -6.00 D. This study indicated that the range of corneal asphericity measured in these 25 eyes, before and after surgery, provided good visual acuity and normal contrast sensitivity.     

One year results of European Multicenter Study of intrastromal corneal ring segments. Part 1: refractive outcomes

PURPOSE: To assess the efficacy, predictability, stability, and safety of correcting myopia with intrastromal corneal ring segments (ICRS, KeraVision, Inc.). SETTING: Twelve European investigational sites. METHODS: Patients with myopia of -1.0 to -6.0 diopters (D) and best spectacle-corrected visual acuity (BSCVA) of 20/20 or better (except in 3 eyes) were assigned to receive 1 of 5 ICRS thicknesses (0.25, 0.30, 0.35, 0.40, or 0.45 mm). Efficacy was assessed by postoperative uncorrected visual acuity (UCVA), predictability of refractive outcome (deviation from predicted cycloplegic refraction spherical equivalent), and stability of refractive effect (manifest refraction spherical equivalent [MRSE]). Safety was assessed by maintenance or loss of preoperative BSCVA and induced manifest refraction cylinder. Measurements were made preoperatively and 1 and 7 days and 1, 2, 3, 6, and 12 months postoperatively. RESULTS: One hundred fifty-nine ICRSs were implanted in the eyes of 107 patients (52 patients had bilateral implantation). Preoperatively, UCVA was worse than 20/40 in 98% of eyes (155/159); 12 months postoperatively, it was 20/20 or better in 63% of eyes (83/132) and 20/40 or better in 96% (127/132). Predicted refractive corrections for each ICRS thickness generally correlated with achieved corrections. At 12 months postoperatively, 90% of eyes (124/138) were within +/-1.00 D of plano (MRSE). Two or more lines of BSCVA were lost in 6% of eyes (8/135); all 8 eyes had BSCVAs of 20/25 or better. CONCLUSION: The ICRS safely, effectively, and predictably reduced or eliminated low to moderate myopia. Refractive correction was stable through the 12 month follow-up.     

Ferrara intrastromal corneal ring segments for severe keratoconus

PURPOSE: Intrastromal Ferrara ring segments were inserted in eyes with severe keratoconus to evaluate safety and efficacy of this procedure. METHODS: Intrastromal Ferrara ring segments were placed in 36 eyes of 35 patients with severe keratoconus, who were evaluated after 12 months of follow-up. All patients had highly disabling visual acuity, contact lens intolerance, and a previous indication for penetrating keratoplasty. Statistical analysis included preoperative and postoperative uncorrected visual acuity, best spectacle-corrected visual acuity, manifest refraction, anterior chamber depth, keratometry, and pachymetry. RESULTS: No patient had a loss of visual acuity. Uncorrected visual acuity improved in 28 eyes (77.78%) and best spectacle-corrected visual acuity improved in 29 eyes (80.56%). Spherical equivalent refraction decreased from -7.29 +/- 3.12 D to -4.80 +/- 3.04 D at 12 months after Ferrara intrastromal ring segment implantation. Corneal topography and ultrasound biomicroscopy showed corneal flattening, demonstrated by thinning of the central cornea and a reduction in anterior chamber depth. Segment decentration occurred in one eye (2.7%), asymmetric positioning of the segments in two eyes (5%), inadequate depth in two eyes (5%), migration of the segments in two eyes (5%), segment extrusion in five eyes (13.8%), conjunctivitis in one eye (2.7%), bacterial keratitis in one eye (2.7%), and hydrops in one eye (2.7%). CONCLUSIONS: With these early results, Ferrara intrastromal ring segments appear to be an alternative for the treatment of severe keratoconus.     

Combined ICRS insertion and LASIK to maximize postoperative residual bed thickness in high myopia

PURPOSE: To describe a new technique and early outcomes of combined intrastromal corneal ring segment (ICRS) insertion and laser in situ keratomileusis (LASIK) to treat patients with moderate to high myopia and thin corneas. SETTING: University-based academic practice, Boston, Massachusetts, USA. METHODS: Combined ICRS insertion and LASIK was performed in 2 stages: ICRS channel formation (stage I) followed by LASIK and ICRS insertion (stage II). RESULTS: Fifteen eyes of 11 patients with a mean preoperative spherical equivalent of -9.98 diopters (D) +/- 2.60 (SD) (range -7.13 to -16.25 D) and mean preoperative astigmatism of 1.11 +/- 0.75 D (range 0.00 to -3.00 D) were treated with combined ICRS insertion and LASIK. The mean central pachymetry was 526.13 +/- 35.69 microm (472 to 579 microm). The uncorrected visual acuity was 20/40 or better in 7 of 15 eyes (46.67%) at 1 month, 6 of 12 eyes (50.00%) at 3 months, 5 of 12 eyes (41.67%) at 6 months, and 6 of 12 eyes (50.00%) at 12 months. The best spectacle-corrected visual acuity was 20/40 or better at all times. Postoperative maps confirmed the absence of ectasia. The postoperative spherical equivalent was within +/-1.00 D of the intended refraction in 11 of 15 eyes (73.33%) at 1 month, 9 of 12 eyes at 3 and 6 months, and 8 of 12 eyes (66.67%) at 12 months. CONCLUSIONS: Results of combined ICRS insertion and LASIK in moderately to highly myopic patients with relatively thin corneas were good. Long-term studies are needed to determine whether this procedure will decrease the risk of LASIK-induced keratectasia in these patients.     

First results of myopia correction with intracorneal ring segments (ICRS)

PROBLEM: The Implantation of intracorneal ring segments (ICRS) offers the possibility of reversible, refractive surgery for correction of lower myopia up to -5.0 D. We report our first results 1 year after implantation of ICR segments. PATIENTS AND METHODS: From April 1997 to August 1998 we implanted ICRS in 48 eyes of 31 patients (12 male, 19 female) to correct myopia. The preoperative refraction (spherical equivalent) was between -1.0 and -5.0 D (astigmatism < 1.0 D). The average age was 34.0 years (range 19-48 years). ICRS implantation was performed in peribulbar anaesthesia. All operations were done by the same surgeon. RESULTS: The average follow-up was 10 months (ranges 1-12 months). After 6 months the deviation from the target refraction of all eyes was < 1.5 D; 26 of 27 eyes (96.3%) showed a deviation of < or = 1.0 D. Six months after surgery, 18 of 27 eyes (66.6%) showed an uncorrected visual acuity of 20/20 or better, 23 of 26 eyes (88.4%) showed 20/25 or better, and 25 of 26 eyes (96.2) 20/40 and better. Only 1 of 16 eyes showed an uncorrected visual acuity of 20/50. In all eyes, the best-corrected visual acuity was 20/20 or better. In 2 eyes an ICRS exchange and implantation of a thicker ring was necessary because the target refraction could not be achieved with the first implanted ring. In 2 eyes an ICRS reposition was done to optimize the location of the ring within the cornea. In 4 eyes we explanted the ring due to double vision (1 x) and distorted vision (3 x) caused by induced astigmatism. After explantation the preoperative refraction (+/- 0.15 D) was reached within 1 to 1.5 months. There was no regression after 6 months (n = 27) or after 1 year (n = 7). CONCLUSION: Our 1-year results of ICRS implantation show that myopia correction with the advantage of reversibility and lower complication rate is possible by this refractive surgical method. Ring exchange and explantation are possible. Earlier postoperative complaints like photophobia, unstable visual acuity or discomfort usually disappear rapidly. The decision of 95.0% of the patients to have ICRS implantation also into the second eye shows the high degree of satisfaction.     

First clinical results with the femtosecond neodynium-glass laser in refractive surgery

PURPOSE: We evaluated four femtosecond laser intrastromal cutting procedures: creation of a corneal flap for laser in situ keratomileusis (LASIK), tunnel and entry cut for intracorneal ring, corneal flap and removable lens for keratomileusis, and intrastromal ablation for myopia and hyperopia. METHODS: A clinical trial using a femtosecond surgical laser (IntraLase Corporation) was performed in partially sighted eyes. Femto-LASIK treatment was performed on 46 eyes up to -14.00 D; 16 patients received intracorneal ring segments (Femto-ICRS); 5 patients each with one highly myopic eye had femtosecond laser keratomileusis (FLK), and 13 patients each with one myopic or hyperopic eye had intrastromal ablation (ISPRK). In Femto-LASIK, excimer laser ablation was done under the flap. In Femto-ICRS, ring segments were introduced into the laser-created channels. In femtosecond laser keratomileusis, a lens-shaped block of stroma was removed manually from under the flap. RESULTS: No difference was found between the results obtained with Femto-LASIK and a standard microkeratome. No refractive effects occurred when the created flap was not elevated. In cases of Femto-ICRS and conventional ICRS produced the same refractive results. With Femto-ICRS, no intraoperative complications occurred and visual acuity improved immediately after surgery. In femtosecond laser keratomileusis, high myopia was corrected without using excimer laser ablation; centralization of the treatment area was excellent. In intrastromal ablation, 1 to 2 hours after surgery the corneas were highly transparent; refractive results were stable. CONCLUSIONS: Femtosecond lasers can produce precise intrastromal cutting, offering significant safety and other advantages (no razor blades, corneal trauma, partial resections, or sterilization issues) over current techniques.     

Two-year outcomes of intrastromal corneal ring segments for the correction of myopia

OBJECTIVE: To evaluate the safety and efficacy of Intrastromal Corneal Ring Segments (ICRS) for the correction of myopia. DESIGN: Nonrandomized, comparative trial. PARTICIPANTS: Patients enrolled in the United States Food and Drug Administration phase II and phase III clinical trials of the ICRS had best spectacle-corrected visual acuity (BSCVA) of 20/20 or better, myopia of -1.00 to -3.50 diopters (D), and a cylindrical correction of 1.00 D or less as measured by manifest refraction. INTERVENTION: Surgical correction of myopia with an ICRS. MAIN OUTCOME MEASURES: Efficacy was assessed by predictability of refractive outcome (deviation from predicted cycloplegic refraction spherical equivalent), stability of refractive effect, and postoperative uncorrected visual acuity. Safety was assessed by adverse events, maintenance or loss of preoperative BSCVA, and induced manifest refraction cylinder. RESULTS: Four hundred fifty-two patients were enrolled at 11 investigational sites in both studies. Of the 454 surgical attempts, 449 received an ICRS in one eye (0.25, 0.30, and 0.35 mm in 148, 151, and 150 eyes, respectively). First surgeries were attempted in 452 patients. An ICRS was successfully implanted in 447 initial eyes, and 5 surgeries were discontinued. Of the five discontinued surgeries, three patients subsequently exited from the study, and two patients went on to have the ICRS implanted in the second eye, bringing the total number of successful implants to 449 patient eyes. Month 24 postoperative follow-up was completed on 358 patients (80%). At month 24, 328 of 354 eyes (93%) were within +/-1.00 D of predicted refractive outcome. Refraction changed by 1 D or less in 97% of eyes (421/435) between 3 and 6 months after implantation and in 99% (343/348) between months 18 and 24. Before surgery, 87% of eyes (390/448) saw worse than 20/40 uncorrected; 24 months after surgery, 55% of eyes (196/358) saw 20/16 or better, 76% (271/358) saw 20/20 or better, and 97% (346/358) saw 20/40 or better. Although two eyes (2/358; 0.5%) lost two or more lines of BSCVA at 24 months; visual acuity in both was 20/20 or better. Intraoperative complications included anterior corneal surface perforation (three eyes) and anterior chamber perforations (two eyes, one during an attempted exchange procedure); all healed spontaneously without suturing and without loss of BSCVA. The ICRS was repositioned in five eyes to increase correction. Postoperative complications in one eye each were infectious keratitis, shallow segment placement, and loss of two lines of BSCVA at two or more consecutive examinations (subsequently regained). CONCLUSIONS: The ICRS safely, predictably, and effectively reduced or eliminated myopia of -1.00 to -3.50 D. The refractive effect was stable over time.     

【In Press】 Clinical outcomes after implantation of a new intrastromal corneal ring with 140-degree of arc in patients with corneal ectasia

AIM: To evaluate the clinical and tomographic outcomes after implantation of a new intrastromal corneal ring segment (ICRS) with 140-degrees of arc in eyes with corneal ectasia. METHODS: We evaluated patients with corneal ectasia implanted with Ferrara 140° ICRS from April 2010 to February 2015. Outcome measures included preoperative and postoperative corrected distance visual acuity (CDVA), keratometry simulated (K) reading, tomographic astigmatism and asphericity (Q). All patients were evaluated using the Pentacam Scheimpflug system. RESULTS: The study evaluated 67 eyes. The mean follow-up was 16.81±13.96mo. The CDVA (logMAR) improved from 0.5±0.20 logMAR (20/60) to 0.3±0.21 logMAR (20/40) (P<0.01). The average K reduced from 49.8±7.01 D to 47.34±4.90 D (P<0.01). The asphericity changed from -0.60±0.86 to -0.23±0.67 (P<0.01). The mean preoperative tomographic astigmatism decreased from -8.0±3.45 D to -4.53±2.52 D (P<0.01). CONCLUSION: The new ICRS model with 140-degrees of arc effectively improved the visual acuity and reduced the high astigmatism usually found in patients with corneal ectasia.     

Adjustability of refractive effect for corneal ring segments

PURPOSE: To evaluate the safety and efficacy of adjustability of the refractive effect of intrastromal corneal ring segments (ICRS, Intacs). METHODS: Data from four patients who had their initial Intacs removed and exchanged for new Intacs of different thickness sizes during a United States Food and Drug Adminstration Phase II clinical trial were evaluated with regard to segment size, reasons for exchange, duration within the cornea before exchange procedure, loss or change of spectacle-corrected visual acuity, change of uncorrected visual acuity, manifest refraction, cycloplegic refraction, topography after exchange, and stability of refraction. RESULTS: The exchange procedure was performed in two patients due to undercorrection and in two for overcorrection. The length of time the segments remained in the cornea after initial surgery varied from 6 to 15 months (mean, 10.25 +/- 4.03 mo). The most recent examination occurred between 4 to 18 months (mean, 10.0 +/- 6.32 mo) following the exchange procedure and showed improved uncorrected visual acuity with a range from 20/16 to 20/20 and a gain of 2 to 7 lines of uncorrected visual acuity compared to baseline. No eyes lost any lines of spectacle-corrected visual acuity following the exchange procedure and all preserved their preoperative spectacle-corrected visual acuity of 20/16. The intended refractive correction was achieved in the first few days of the exchange procedure and remained stable. CONCLUSION: In these four eyes that were over- or undercorrected after initial Intacs placement, segment thickness sizes were exchanged after 6, 8, 12, and 15 months without complication and with final uncorrected visual acuities of 20/16 to 20/20.     

Clinical outcomes after implantation of a new intrastromal corneal ring with 140-degree of arc in patients with corneal ectasia

AIM: To evaluate the clinical and tomographic outcomes after implantation of a new intrastromal corneal ring segment (ICRS) with 140-degrees of arc in eyes with corneal ectasia. METHODS: We evaluated patients with corneal ectasia implanted with Ferrara 140° ICRS from April 2010 to February 2015. Outcome measures included preoperative and postoperative corrected distance visual acuity (CDVA), keratometry simulated (K) reading, tomographic astigmatism and asphericity. All patients were evaluated using the Pentacam Scheimpflug system. RESULTS: The study evaluated 58 eyes. The mean follow-up was 16.81±10.8mo. The CDVA (logMAR) improved from 0.5±0.20 (20/60) to 0.3±0.21 (20/40) (P<0.01). The average K reduced from 49.87±7.01 to 47.34±4.90 D (P<0.01). The asphericity changed from -0.60±0.86 to -0.23±0.67 D (P<0.01). The mean preoperative tomographic astigmatism decreased from -8.0±3.45 to -4.53±2.52 D (P<0.01). CONCLUSION: The new ICRS model with 140-degrees of arc effectively improve the visual acuity and reduce the high astigmatism usually found in patients with corneal ectasia.     

Experimental imaging of intracorneal ring segments with optical coherence tomography

PURPOSE: To investigate the imaging of corneal structures with optical coherence tomography (OCT) after implantation of intracorneal ring segments (ICRS). METHODS: In an experimental study with six porcine eyes, qualitative and quantitative imaging with corneal OCT using a wavelength of 1310 nm after implantation of ICRS was performed. The optical results were compared with light microscopy of the histological sections. RESULTS: In corneal OCT, the ICRS revealed marked hyporeflective intrastromal areas, which correlated well with macroscopic and microscopic findings. Corneal OCT enabled precise images of the incision depth for the implantation of ICRS, and the exact intrastromal segment position. CONCLUSIONS: Noncontact slit lamp-adapted corneal optical coherence tomography could be employed to clinically monitor corneal changes after implantation of ICRS, evaluate the depth of the segments to correlate refractive changes, and quantify the stromal wound healing response.     

Fluctuations in uncorrected visual acuity after refractive surgery using intra-stromal corneal rings]

PURPOSE: Refractive surgery is meant to provide early stable and good uncorrected visual acuity. Our main concern in this study was to take special interest in fluctuation in uncorrected acuity within the first three months after implantation of Schanzlin intracorneal ring segments (ICRS) produced by Keravision. PATIENTS AND METHODS: Ten eyes in 6 patients underwent implantation of 2 intrastromal corneal segments for myopias ranging from -1.00 to -3.50 Dipoters. Visual acuity was measured with cytoplegy on day one, on day 8, two weeks, 1 month, and 2 months after surgery. The fluctuations of visual acuity were noted between observations. RESULTS: Uncorrected visual acuity varied up to 4 lines without an obvious pattern of progression over time. Fifty percent of the eyes had a variation of 2 lines. The best spectacle corrected visual acuity was preserved in all patients. DISCUSSION: Corneal topography with measurement of keratometry, intraocular pressure, and examination of the anterior chamber must be studied to identify the parameter that could condition these fluctuations of visual acuity. No parameter was found to predict these variations that may result from individual corneal healing factors peculiar to each patient. The fluctuations of uncorrected visual acuity were relatively important during the 3 first postoperative months. In all patients, final uncorrected visual acuity was always at least 10/10.     

Evaluation of anterior and posterior surfaces of the cornea using a dual Scheimpflug analyzer in keratoconus patients implanted with intrastromal corneal ring segments

AIM: To evaluate corneal parameters measured with a dual Scheimpflug analyzer in keratoconus patients implanted with intrastromal corneal ring segments (ICRS). METHODS: Fifty eyes of 40 keratoconus patients had Ferrara ICRS implantation from November 2010 to April 2014. Uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), refraction, keratometry, asphericity, elevation, pachymetry, root mean square (RMS), spherical aberration and coma were studied. All patients were evaluated using a dual Scheimpflug system. RESULTS: The mean follow-up time after the procedure was 12.7mo. The mean UCVA improved from 0.82 to 0.31 (P<0.001); the mean BCVA improved from 0.42 to 0.05 (P<0.0001), the mean spherical refraction changed from -3.06±3.80 D to -0.80±2.5 D (P<0.0001) and the mean refraction astigmatism reduced from -4.51±2.08 D to -2.26±1.18 D (P<0.0001). The changes from preoperative to postoperative, in parameters of the anterior and posterior surface of the cornea, were statistically significant except the elevation posterior at the apex of the cornea and posterior asphericity. CONCLUSION: The implantation of Ferrara ICRS induces changes in both anterior and posterior surfaces of the cornea.     

圆锥角膜基质环植入手术前后人工晶状体度数的比较

目的:评估圆锥角膜基质环(keraring 355°)(ICRS)植入术前术后3mo人工晶状体(IOL)度数的计算和生物学特征.方法:队列研究.收集18例(19眼)圆锥角膜接受角膜基质环植入术患者术前及术后3mo数据.分析裸眼视力(UCVA), 最佳矫正视力(BCVA),屈光度,人工晶体度数计算公式,眼轴长度(AL)和角膜曲率.结果:患者平均年龄为29.58±0.6y.裸眼视力由0.84(0.35) LogMAR 显著提高到0.43 (0.31) LogMAR (P<0.001).3mo后,最佳矫正视力和眼轴长度无明显变化.球镜度数,柱镜度数和等效球镜(SE)均显著提高 (P<0.001).另一方面,角膜曲率1(K1)和角膜曲率2(K2)显著下降.3mo后, SRK/II (P<0.001), Hoffer Q (P<0.001) and Holladay I (P<0.001)发生显著变化.结论:角膜基质环植入术后,视力,屈光率和角膜曲率均有所提高,此外,人工晶状体计算公式度数明显改变.然而,角膜基质环植入术过程没有过度干预眼轴长,但降低角膜曲率值使得人工晶状体度数计算更加精确,所有公式得出同一晶状体度数.