Cross-linking and intrastromal corneal ring segment

Corneal cross-linking is a procedure used for stabilizing the cornea in patients with progressive keratoconus by increasing corneal rigidity, and it is also used in corneal inflammatory melting process. The intrastromal corneal ring segments act by flattening the center of the cornea. Originally designed for the correction of mild myopia, the segments are now being used for reduction of keratoconus in order to improve the uncorrected visual acuity, the best spectacle corrected visual acuity, to allow good tolerance to the use of contact lenses and delay the need for corneal grafting procedures. The present text presents a review of corneal cross-linking and insertion of intrastromal corneal ring segments, emphasizing their indications, results and complications related until now.     

Photorefractive keratectomy after intrastromal corneal ring segment explantation

PURPOSE: To describe a case of photorefractive keratectomy after removal of intrastromal corneal ring segments from the cornea. METHODS: During United States Food and Drug Administration Phase III Trials for intrastromal corneal ring segments (ICRS), the implanted segments were removed from the cornea of the right eye of a patient because of dissatisfaction with glare, halos, and fluctuating vision. Ten months after ICRS explantation, the-patient underwent a photorefractive keratectomy procedure to the same eye. RESULTS: One month after removal of the ICRS, the patient's manifest refraction was within +/- 0.50 diopters of his original manifest refraction. Photorefractive keratectomy was planned to the same eye 6 months later. At the first attempt, the epithelium could not be removed with the laser and scrape technique, and residual epithelium was noted at the vertical meridian (12 o'clock) corneal incision site, which had been used for ICRS surgery and explant; therefore, the procedure was aborted. At the second attempt, with a mechanical epithelial brush (AMOILS Epithelial Scrubber; Innova, Inc, Toronto, Canada), the epithelium was removed with ease. After this, photorefractive keratectomy was done without difficulty or complication. At his most recent 8-month postphotorefractive keratectomy examination, the patient had an uncorrected visual acuity of RE: 20/16, with a manifest refraction of -0.75 to 0.75 x 170 degrees, a faint haze at the site of the stromal channel, and a small scar at the incision site on slit-lamp examination. CONCLUSIONS: Intrastromal corneal ring segments can be readily removed from the cornea, if required. In this case, the refraction returned to its preoperative state soon after the explant procedure and remained stable over time. Photorefractive keratectomy was performed as a secondary refractive surgical procedure after the removal of ICRS without difficulty or complication. However, removal of the epithelium is probably best accomplished with the use of an epithelial brush, considering the changes in the epithelial adherence in a postsurgical cornea. Further studies are required to establish the safety and efficacy of secondary refractive surgical procedures after ICRS explantation.     

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.     

Effect of intrastromal corneal ring segment shift on clinical outcome: one year results for low myopia

PURPOSE: To evaluate the effect of intrastromal corneal ring segment (ICRS) shift on clinical outcome. SETTING: Chu Morvan Ophthalmology Service, Brest, France. METHODS: Forty-seven eyes with myopia from -1.0 to -5.0 diopters (D) had ICRS surgery according to United States Food and Drug Administration protocol using a 2-segment implant design. Visual acuity, refractive, videotopographic, and biomicroscopic results in eyes that did not have contact between segments (Group A, n = 26) and in eyes that did have contact (Group B, n = 21) were compared. RESULTS: Soon after surgery, migration of and subsequent contact between the implant segments occurred in 21 eyes (45%). Contact between the inferior ends was most common, occurring in 19 eyes; in the remaining 2 eyes, the superior ends of the implant touched. Superior contact was associated with superficial channels, wound-healing problems, and ICRS explantation. No segment shift was observed after the first postoperative week. No significant differences in visual acuity, qualitative vision, or density of intrastromal deposits were noted between the 2 groups. However, at 6 months there was more induced with-the-rule cylinder in Group B (mean +1.3 D +/- 0.7 [SD]) than in Group A (mean +0.7 +/- 0.5 D). Astigmatism was clinically significant in only 3 cases at 3 months. CONCLUSIONS: Induced cylinder remains a limitation of the ICRS procedure, and segment contact appears to influence the rate of induced cylinder. Overall, however, the ICRS procedure produces promising results. Research efforts are underway to address induced cylinder and channel deposits associated with ICRS surgery.     

Late dislocation of intrastromal corneal ring segment into the anterior chamber

We describe the case of a 53-year-old woman with keratoconus who presented with a dislocated intrastromal corneal ring segment (ICRS) (Intacs) in the anterior chamber 3 weeks after surgery. To our knowledge, this is the first report of a late occurrence of postoperative anterior chamber dislocation of an ICRS and illustrates the need to consider the potential for such a complication.     

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.     

Influence of intrastromal corneal ring segment implantation on corneal biomechanical parameters in keratoconic eyes

Purpose  

To assess the influence of intrastromal corneal ring segment (ICRS) implantation on corneal biomechanics in patients with keratoconus.     

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.     

Preliminary results of a new intrastromal corneal ring segment as a tissue saving procedure in photorefractive keratectomy to correct moderate to high myopia

AIM: To investigate changes in macular vessels and thickness in myopic eyes after intraocular collamer lens (ICL) implantation using quantitative optical coherence tomography angiography (OCTA). METHODS: This retrospective included 73 myopic eyes of 73 patients (average age, 27.53±6.16y) who underwent ICL implantation (28 eyes were Toric ICL). Axial length (AL), uncorrected visual acuity (UCVA), refractive dioptre (RD), intraocular pressure (IOP) and OCTA were measured and compared with before and 1wk, 1, and 3mo after surgery. OCTA was used to image vessel density (VD) and skeleton density (SD) in both the superficial (SCP) and deep capillary plexus (DCP). Central retinal thickness (CRT) and ganglion cell-inner plexiform layer thickness (GCT) were also measured. Changes between pre- and postoperative measurements were analysed by repeated measures analysis of variance. RESULTS: Compared with preoperative data, postoperative data on UCVA revealed significant improvements in all patients (P<0.05). However, there was no significant difference in IOP. After the operation, CRT and GCT exhibited significant changes (P<0.05). Among these measures, CRT was significantly higher at one and three months postoperative (all P<0.01). GCT was significantly higher at 1wk, 1, and 3mo postoperative (all P<0.01). Changes in VD and SD were nonsignificant in both the SCP and DCP. There was no difference in postoperative changes between the ICL and Toric ICL groups. CONCLUSION: ICL and Toric ICL implantation both have good efficacy and safety for myopic eyes, but macular area changes that occur after surgery need attention.     

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.