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.     

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.     

Photorefractive keratectomy for myopia in the setting of adenoviral subepithelial infiltrates

PURPOSE: To report a patient with persistent subepithelial corneal opacities 18 months after adenoviral keratoconjunctivitis who underwent photorefractive keratectomy for the correction of myopia.METHODS: Case report, review of medical literature, and slit-lamp photography.RESULTS: The patient underwent photorefractive keratectomy in each eye, 1 week apart, with ablation of central corneal opacities and resultant best-corrected visual acuity of BE, 20/20. Symptomatic subepithelial stromal infiltrates recurred in the peripheral but not the central cornea of each eye 3 months after laser treatment.CONCLUSIONS: Photorefractive keratectomy was successful in the correction of myopia and prevented the recurrence of adenoviral subepithelial corneal infiltrates within the laser-treated central cornea.     

Diurnal variations in keratometry and refraction with intracorneal ring segments.

PURPOSE: To study refraction variations during the day in eyes with intrastromal corneal ring segments (ICRS) to correct low myopia. SETTING: Monticelli Clinic, Marseille, France. METHODS: Thirteen eyes with ICRS were included in the study; the ICRS was explanted from 3 eyes because of undercorrection. The minimum follow-up in all eyes was 1 year. The same observer measured refraction and keratometry at 9:00 AM, 1:00 PM, and 7:00 PM with the same autokeratorefractometer. To validate the analysis method, these eyes were compared with a group of emmetropic control eyes that had not had surgery and with a group of eyes that had photorefractive keratectomy for a similar degree of myopia. All measurements were done under the same conditions. RESULTS: After 1 year, the ICRS eyes showed a tendency toward an evening myopic shift. This was confirmed by the objective keratometry study, which showed variations closely correlated with the myopia observed. These phenomena were not observed in the other groups. CONCLUSION: The ICRS had satisfactory predictability in eyes with up to -3.50 diopters of myopia. However, the evening myopic shift appeared similar to that observed after radial keratotomy.     

Photorefractive keratectomy for myopia in the setting of Thygeson's superficial punctate keratitis

PURPOSE: To describe a patient with Thygeson's superficial punctate keratitis who underwent photorefractive keratectomy for the correction of myopia. METHODS: A 49-year-old woman with unilateral Thygeson's keratitis was examined before and after photorefractive keratectomy. RESULTS: A myopic patient underwent photorefractive keratectomy in the left eye and gained 20/20 uncorrected visual acuity. Seventeen months after surgery, symptomatic Thygeson's keratitis lesions recurred in the peripheral but not the central cornea. CONCLUSION: Photorefractive keratectomy reliably corrected myopia in a patient with previous Thygeson's keratitis. The recurrence of lesions only in the peripheral untreated cornea suggests that the inflammatory signal in Thygeson's keratitis may reside in the superficial corneal stroma.     

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.     

Intraocular pressure measurement in patients with instrastromal corneal ring segments.

PURPOSE: To study the measurement of intraocular pressure after implantation of Intacs (ICRS) intrastromal corneal ring segment, a device that is positioned circumferentially in the peripheral corneal stroma to correct myopia. The device changes the corneal curvature by shortening arc length. Since the ring segments are made of polymethylmethacrylate, this may cause localized changes in corneal elasticity so intraocular pressure measurement may be affected. METHODS: We measured the intraocular pressure of 12 eyes in which the ICRS had been in place longer than 6 months. We used Goldmann applanation and Tono-Pen tonometers over the central corneal and the paracentral corneal areas. We also measured the intraocular pressure with the Tono-Pen applanated directly over the intrastromal corneal ring segments. RESULTS: The resulting intraocular pressure measurements were similar for the Tono-Pen tonometer readings over the central cornea, paracentral cornea, and the Goldmann applanation tonometer readings over the central cornea (P < .01). Our measurements using the Goldmann applanation tonometer on the paracentral corneal area showed artificially elevated intraocular pressure in the 40 to 60 mmHg range. We were not able to obtain consistent results when we measured the intraocular pressure using the Tono-Pen on the corneal area directly overlying the intrastromal corneal ring segment implants. CONCLUSION: Consistent intraocular pressure measurements on eyes with the ICRS can be obtained with the Goldmann applanation tonometer over the central corneal area or with the Tono-Pen tonometer over the central or paracentral corneal areas.     

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.     

Toric Artisan after transepithelial topography-guided photorefractive keratectomy for higher-order aberrations following intrastromal corneal ring segments in keratoconus – Trioptics

We report a case of a 40-year-old female with keratoconus and high myopia who had previous ICRS implantation in both eyes (OU) and was intolerant to contact lenses. Manifest refraction was - 8.50 - 1.50 × 95 (20/25-- ) in right eye (OD) and - 9.50 - 2.50 × 60 (20/70-- ) in left eye (OS). A topography-guided transepithelial-photorefractive keratectomy (ttPRK) was performed to correct high-order aberrations on OS, resulting in corneal surface and coma improvement, and CDVA achieved 20/30. Correction of residual ametropia was performed with an iris-fixated toric phakic lens in OU. CDVA improved to 20/20- (Plano) in OD and 20/20- (Plano - 1.00 90°) in OS. In conclusion, it is possible to rehabilitate a patient with keratoconus and high ametropia after intrastromal corneal ring segments (ICRS) implantation associating ttPRK and phakic lens (”Trioptics”).     

Spontaneous breakage of intracorneal ring segments (ICRS) 8 years after implantation

We present a case of spontaneous in situ breakage of intracorneal ring segments (ICRSs) 8?years after their implantation in a patient with keratoconus. The patient presented to our clinic with a red and painful right eye that had not improved despite topical steroids and antibiotics. The decision was made to explant the broken ICRSs from the cornea and send them for laboratory analyses, by which manufacturer defects were excluded. It is noteworthy that corneal curvature re-steepening was observed 4?months after ICRS removal despite the performance of crosslinking (CXL) 1?year prior to ICRS implantation.     

Corneal cross-linking (CXL) combined with refractive surgery for the comprehensive management of keratoconus: CXL plus

The past two decades have witnessed an unprecedented evolution in the management of keratoconus that demands a holistic approach comprising of inhibiting the ectatic progression as well as visual rehabilitation. The advent of corneal cross-linking (CXL) in the late 1990s resulted in long-term stabilization of the ectatic cornea along with limited reduction in corneal steepening and regularization of corneal curvature. However, CXL as a standalone procedure does not suffice in rehabilitating the functional vision especially in patients who are unwilling or intolerant towards contact lenses. The concept of “CXL plus” was proposed which incorporates adjunctive use of refractive procedures with CXL in order to overcome the optical inefficiency due to corneal irregularity, decrease the irregular astigmatism, correct the residual refractive error and improve functional visual outcome in keratoconus. Several refractive procedures such as conductive keratoplasty (CK), photorefractive keratectomy (PRK), transepithelial phototherapeutic keratectomy (t-PTK), intrastromal corneal ring segments (ICRS) implantation, phakic intraocular lens (PIOL) implantation and multiple other techniques have been combined with CXL to optimize and enhance the CXL outcome. This review aimed to summarize the different protocols of CXL plus, provide guidelines for selection of the optimum CXL plus technique and aid in decision-making for the comprehensive management of cases with primary keratoconus in addition to discussing the future and scope for innovations in the existing treatment protocols.     

Comparison of changes in manifest refraction and corneal power after photorefractive keratectomy

PURPOSE: To determine which corneal curvature values most closely correlate to change in manifest refraction after excimer laser photorefractive keratectomy. METHODS: In a prospective study at the Cullen Eye Institute, excimer laser photorefractive keratectomy was performed on 27 eyes of 27 patients (mean age, 38.07+/-6.65 years). Preoperative refractive errors ranged from -2.25 diopters to -8.75 diopters (mean, -5.74+/-2.09 diopters). Preoperatively and 1 month postoperatively, we determined the spherical equivalent of the subjective manifest refraction (corrected for a 12-mm vertex distance) and measured corneal power using standard keratometry (Bausch & Lomb Keratometer; Rochester, New York) and computerized videokeratography (EyeSys Corneal Analysis System; Premier Laser Systems Inc, Houston, Texas). We collected 15 corneal values: standard keratometry and 14 computerized videokeratography values calculated using the axial, instantaneous, and refractive formulas. All calculations were performed with 1.3375 and 1.376 for the refractive index of the cornea. For each of the corneal values, we subtracted the change in corneal power from the change in manifest refraction and calculated for this difference the means, SDs, correlations, and regressions. RESULTS: Mean differences between change in refraction and change in corneal power were lower when for a refractive index of 1.376 than for 1.3375, were lowest for the most central measurement points, and displayed a high SD. A value of 1.408 for the refractive index would be required to optimize the correlation between change in manifest refraction and effective refractive power of the central 3 mm of the cornea. CONCLUSIONS: For individual patients who have undergone photorefractive keratectomy, changes in corneal values determined by computerized videokeratography or by standard keratometry do not reliably predict change in manifest refraction.     

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.     

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.     

Laser in situ keratomileusis after intracorneal rings. Report of 5 cases

PURPOSE: To examine the results of laser in situ keratomileusis (LASIK) after removal of intracorneal ring (ICR) segments. SETTING: Active refractive surgery practice. METHODS: The effect of ICR (0.45 mm) placement, the rapidity of refractive recovery after explantation, and the results of subsequent LASIK were examined in 5 eyes. RESULTS: Four eyes developed induced astigmatism after ICR implantation. In 2 of these eyes, retained astigmatism was evident by manifest refraction or corneal topography even after ICR explantation. In 1 eye, the ICR procedure was aborted because of an intraoperative complication. All 5 eyes had subsequent uneventful LASIK. CONCLUSIONS: Intracorneal rings can induce astigmatism that may be retained even after explantation. Careful wound manipulation may reduce the incidence of this complication. Laser in situ keratomileusis after ICR removal appears to be safe and effective.     

Comparison of topographic corneal irregularity after LASIK and intrastromal corneal ring segments in the same patients

PURPOSE: To retrospectively compare the irregularity of the corneal surfaces of 14 patients after LASIK in 1 eye and placement of intrastromal corneal ring segments (ICRS) in the other eye. METHODS: In a within-patient comparison, Orbscan corneal topography was used to retrospectively compare the corneal surface irregularity of LASIK-treated and ICRS-treated eyes at an outpatient tertiary-care ophthalmology clinic in Sao Paulo, Brazil. For the anterior corneal surface, irregularity measurements were compared for both the central and peripheral areas of the cornea. The differences between each group were analyzed for statistical significance. RESULTS: The corneal surfaces of eyes treated with ICRS were found to be more irregular than the corneal surfaces of eyes treated with LASIK, the mean irregularity being 1.91 for LASIK-treated eyes and 3.12 for ICRS-treated eyes in the anterior corneal surface and 0.51 for LASIK-treated eyes and 0.87 for ICRS-treated eyes in the posterior corneal surface. A statistically significant difference was noted only in the posterior surfaces. CONCLUSIONS: When measured with Orbscan topography, ICRS-treated eyes show more corneal surface irregularity than LASIK-treated eyes. The difference in outcome for the two types of treatment may be due to the mechanical effect of the ICRS on the shape of the cornea.     

Photorefractive keratectomy for the correction of residual refractive error with Intacs intrastromal corneal ring segments in place

PURPOSE: To evaluate the efficacy and safety of photorefractive keratectomy (PRK) for residual refractive errors in patients who had previous insertion of intrastromal corneal ring segments (Intacs, Addition Technology, Inc.) for treatment of low myopia. SETTING: Shiley Eye Center, University of California San Diego, La Jolla, California, USA. METHODS: This retrospective case series comprised patients who had Intacs segment implantation and subsequently developed myopic regression. Eight eyes of 5 patients had PRK over the Intacs in situ for the correction of the residual refractive error. RESULTS: Six (75%) of the 8 eyes had plano refraction with 20/20 or better uncorrected visual acuity (UCVA) 1 month after PRK enhancement. Three months postoperatively, all eyes had plano refraction with 20/20 or better acuity. At the last follow-up examination (up to 2 years), all eyes had near plano vision (20/10 to 20/25). The corneal surface epithelium in all eyes healed in 3 to 5 days. One patient had subepithelial haze in both eyes, which resolved with epithelial scraping with mitomycin-C (MMC) application and a phototherapeutic keratectomy enhancement. CONCLUSIONS: This small series showed that PRK can be used to treat residual refractive error after Intacs insertion. The UCVA was 20/25 or better in all cases after PRK enhancement. The incidence of post-PRK haze in this series of patients was high; topical MMC might be used in future cases to mitigate the problem.     

Photorefractive keratectomy retreatment after LASIK

PURPOSE: To study the results of late photorefractive keratectomy (PRK) in corneas originally subjected to LASIK. METHODS: Seven eyes of seven patients who had LASIK for myopia were retreated with PRK at least 2 years after LASIK. Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), refraction, and haze were evaluated before and after LASIK and after retreatment by PRK. RESULTS: Photorefractive keratectomy retreatment improved BSCVA in six (86%) of seven eyes, and one (14%) eye showed no changes. None of the eyes lost lines of BSCVA. Five of seven eyes developed mild haze, which disappeared before the last postoperative follow-up. CONCLUSIONS: Photorefractive keratectomy retreatment performed at least 2 years after LASIK can improve visual acuity. We hypothesize that LASIK-induced corneal nerve damage disturbs corneal wound healing by increasing the tendency for development of haze.