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.

Intraocular lens power calculations using corneal topography after photorefractive keratectomy.

PURPOSE: To report two patients (two eyes) with previous photorefractive keratectomy, who subsequently underwent cataract extraction years later. DESIGN: Case reports. METHODS: Corneal topography was used to determine corneal power used in intraocular lens power calculations. RESULTS: In two eyes of two patients, intraocular lens calculations after photorefractive keratectomy were inadequate, which resulted in a hyperopic postoperative refractive error requiring implantation of a piggyback intraocular lens. CONCLUSION: Corneal topography to determine corneal power in patients with previous photorefractive keratectomy may result in unpredictable intraocular lens power calculations. The clinical history method is the standard to determine corneal power and should be considered in intraocular lens calculations before cataract surgery. We recommend supplying refractive patients with preoperative data for use in future formulas for intraocular lens selection.

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.

LASIK enhancements.

As the field of refractive surgery continues to evolve, an increasing number of surgical options are available for LASIK enhancements. Nonetheless, older methods such as AK continue to play an important role in enhancement procedures. Improvements in instruments and techniques allow for previously made LASIK flaps to be safely lifted for additional myopic or hyperopic ablations. Newer methods such as Intacs placement provide an effective option for patients who are not good candidates for further ablative procedures. These advancements allow refractive surgeons to treat a wider range of myopia, hyperopia, and astigmatism effectively in eyes with a history of LASIK surgery.

Photoastigmatic refractive keratectomy in myopes. Nidek US Investigators Group.

PURPOSE: Photoastigmatic refractive keratectomy (PARK) was studied in a multi-center clinical trial. The Nidek EC-5000 excimer laser was evaluated for its effect on refraction, visual acuity, and safety measures as part of a U.S. Food and Drug Administration (FDA) regulated study. METHODS: Eight U.S. centers enrolled adults with eyes having refractive astigmatism up to 4.00 D and a myopic spherical equivalent refraction up to -8.00 D. Results are reported for 749 eyes of 486 patients with at least 6 months follow-up. The rectangular beam scanning Nidek EC-5000 used a 5.5-mm-diameter treatment zone, a 7.0-mm-diameter peripheral blend zone, and a 40 Hz pulse rate for surface treatment of myopic astigmatism. Nomogram corrections to machine settings were required to achieve the desired results. RESULTS: Preoperative average spherical equivalent refraction of -4.90+/-1.74 D was reduced to -0.02+/-0.79 D at 6 months. Refractive stability was established at 3 months. Over 62% of eyes were within +/-0.50 D of desired correction at 6 months, with over 86% within +/-1.00 D. Uncorrected visual acuity improved by an average of 10 Snellen lines; over 64% of eyes saw 20/20 or better uncorrected and over 93% saw 20/40 or better uncorrected at 6 and 12 months. PARK treatment effectively reduced astigmatism with little average axis error or magnitude error. Corneal haze and safety concerns were minimal. CONCLUSIONS: Photoastigmatic refractive keratectomy using the Nidek EC-5000 excimer laser provided significant reduction of myopia and astigmatism, with minimal complications.

Intacs After Laser in situ Keratomileusis: A Preliminary Report.

PURPOSE: To assess the corneal topographic and refractive results and feasibility of placing Intacs in eyes with a history of previous laser in situ keratomileusis (LASIK) surgery. METHODS: This was a prospective study on 25 eyes with residual myopia between -0.75 and -3.00 D. Residual myopia in these patients was secondary to regression or planned undercorrection due to preoperative thin corneas. RESULTS: Main outcome measures included uncorrected visual acuity, preservation of best spectacle-corrected visual acuity, refractive predictability, corneal topographic changes, and evaluation of surgical complications. CONCLUSIONS: Initial Intacs procedures after previous LASIK were performed uneventfully. In addition to correcting residual myopia, these procedures may improve night vision symptoms in some patients. These cases may improve our understanding of the ideal corneal shape. [J Refract Surg 2000;1 6(suppl):S236-S238].

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.

Improvement of visual function with glare testing after photorefractive keratectomy and radial keratotomy.

PURPOSE: To evaluate the effect of a glare source on visual function in patients after photorefractive keratectomy and radial keratotomy. METHODS: Thirteen patients (22 eyes) who underwent photorefractive keratectomy and 20 patients (40 eyes) who underwent radial keratotomy were evaluated in this cross-sectional study. LogMAR visual acuity and contrast sensitivity were measured. Pupils were measured with the Rosenbaum card. A halogen/tungsten glare source approximated the luminance of headlights of an oncoming car at 100 feet. RESULTS: In the photorefractive keratectomy and radial keratotomy groups, pupils were significantly smaller (P<.01) and the pupillary clearance of the ablation zone in photorefractive keratectomy and the clear zone in radial keratotomy were significantly larger under the glare condition (P<.01). In the photorefractive keratectomy group, visual acuity and contrast sensitivity under the glare condition were significantly higher than in the no-glare condition (P = .02). In the radial keratotomy group, contrast sensitivity under the glare condition was significantly higher than under the no-glare condition (P = .001 to .003). CONCLUSIONS: After photorefractive keratectomy or radial keratotomy, the traditional glare source constricted the pupil and partially masked the optical aberrations, which resulted in an improvement in visual function. A "pupil-sparing" aberration test is needed for evaluation of visual function after refractive surgery.

One-year results from the phase III investigation of the KeraVision Intacs.

BACKGROUND: Limitations of the surgical correction for myopia include inaccuracy, instability, treatment of the central optical zone, and lack of reversibility. KeraVision Intacs offer an alternative that addresses these shortcomings. METHODS: We present 1 year of follow-up information on 95 subjects enrolled in the United States Food and Drug Administration Phase III clinical trials. RESULTS: At 1 year, 99% of patients (89 of 90) had 20/40 uncorrected vision or better. Ninety-two percent of eyes (83 of 90) were within 1.00 D of intended correction and 76% of eyes (68 of 90) were within 0.50 D of intended correction. Stability was achieved at 3 months, with 96% of subjects (86 of 90) having less than 1.00 D of change from their previous examination. In a substudy, 89% eyes (58 of 65) varied within +/- 0.50 D over the course of a day. Corneal curvature changed as predicted, resulting in a prolate aspheric shape within the central optical zone. Most complications or adverse events experienced were managed with additional medication or surgical intervention, resulting in a favorable outcome for subjects. CONCLUSIONS: KeraVision Intacs are effective, predictable, stable, and safe. This additive technique may also offer 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.

Phototherapeutic keratectomy for recurrent erosion syndrome in anterior basement membrane dystrophy.

PURPOSE: To determine the outcome of patients who received phototherapeutic keratectomy (PTK) for recurrent erosion syndrome due to anterior basement membrane dystrophy (ABMD). DESIGN: A retrospective, noncomparative case series. PARTICIPANTS: Forty-eight eyes of 43 consecutive patients who underwent PTK for recurrent erosions occurring in ABMD at the Hunkeler Eye Center from 1991 to April 1995. All patients had previously failed at least one method of medical or surgical treatment for recurrent erosions and had slit-lamp findings of ABMD on initial evaluation. INTERVENTION: The eyes each underwent manual superficial keratectomy and PTK with the Summit Omnimed excimer laser. MAIN OUTCOME MEASURES: Data were analyzed by a retrospective chart review for 1, 3, 6, and 12 months for the 36 eyes with at least 12 months of follow-up data available. They were analyzed for preoperative and postoperative visual acuity, change in spherical equivalent, recurrence rate, and patient satisfaction. RESULTS: The preoperative mean visual acuity was not statistically significantly different at 1 month after PTK. Statistically significant improvement in mean visual acuity was present at 3, 6, and 12 months. Recurrence of symptoms of recurrent erosion was present in 5 (13.8%) of 36 eyes during the 12-month follow-up period, which was managed with repeat PTK over the area of the cornea initially treated with PTK; 1 of 5 required a third PTK treatment. All recurrences presented within 6 months of PTK or repeat PTK. The mean dioptric change in spherical equivalent was not statistically significant. Patient satisfaction levels after PTK for recurrent erosions in ABMD were assessed in 21 (58%) of 36 patients on a scale of 0 to 5 (5 = most satisfied); the mean response was 4.14 of 5. CONCLUSIONS: Phototherapeutic keratectomy is an effective treatment for recurrent erosions occurring in the setting of ABMD, is well tolerated, and may improve visual acuity. The rate of recurrence of erosions in ABMD treated with PTK is low during a 12-month follow-up period.

Lift-flap retreatment after laser in situ keratomileusis.

PURPOSE: To demonstrate the effectiveness of lifting the flap for retreatment of undercorrected eyes after laser in situ keratomileusis (LASIK). METHODS: We reviewed the results of 11 LASIK patients (12 eyes) who underwent retreatment for residual myopia by lifting the previously cut flap. This was followed by treatment with the Summit Apex excimer laser and repositioning of the flap. Average time prior to retreatment was 5 months (range, 1 to 9 mo). Follow-up was 100% at 3 months after retreatment. RESULTS: The average preoperative spherical equivalent refraction was -8.73 D; average prior to retreatment was -2.24 D (range, -0.67 to -5.75 D). At 1 month after retreatment, average deviation from intended correction was 0.08 D; at 3 months it was -0.12 D. Eleven of 12 treated eyes (92%) had uncorrected visual acuity of 20/40 or better and 4 eyes (33%) saw 20/20 or better without correction. Six eyes (50%) were within +/- 0.50 D of intended correction at 3 months. No patients lost any lines of spectacle-corrected visual acuity. CONCLUSION: Retreatment of residual myopia after LASIK by lifting the flap appears to be effective and associated with minimal complications.

Role of clearance and treatment zones in contrast sensitivity: significance in refractive surgery.

PURPOSE: To evaluate the relationship between contrast sensitivity, surgical treatment zone, and clearance (ablation or clear zone-pupil diameter) in photorefractive keratectomy (PRK) and radial keratotomy (RK). SETTING: Saint Louis University Eye Institute, St. Louis, Missouri, and Hunkeler Eye Center, Kansas City, Missouri, USA. METHODS: Thirteen patients had PRK and 20, RK. Contrast sensitivity was measured with the Stereo Optical F.A.C.T. (F.A.C.T.) and VectorVision CSV-1000 (VV) charts. Pupils were measured with the Rosenbaum card. RESULTS: In the PRK group, VV contrast sensitivity at 6 and 12 cycles per degree (cpd) correlated with the ablation zone (r2 = 0.18 and 0.22, respectively), while visual acuity and F.A.C.T. contrast sensitivity did not correlate. In the RK group, both VV and F.A.C.T. contrast sensitivity at 6 cpd correlated with clearance (r2 = 0.29 and 0.12, respectively). Pupils were larger with the VV test than with the F.A.C.T. chart because ambient chart luminance was less in the former. CONCLUSION: Contrast sensitivity is likely a more sensitive indicator of visual function than acuity in refractive surgery. The VV system unmasks aberrations from the transition zone of ablated and unablated cornea in PRK. Larger samples are needed to determine the critical ablation clearance of the pupil to avoid loss of visual function.

Photorefractive keratectomy versus laser in situ keratomileusis for moderate to high myopia. A randomized prospective study.

OBJECTIVE: This report presents the results of a randomized clinical trial of photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis (LASIK). DESIGN: A randomized, prospective multicenter clinical trial. PARTICIPANTS: A total of 220 eyes of 220 patients entered the study cohort: 105 randomized to PRK and 115 to LASIK. The mean preoperative manifest refraction spherical equivalent was -9.23 diopters (D) in the PRK group and -9.30 D in the LASIK group. INTERVENTION: All patients received a one-pass, multizone excimer laser ablation as part of either a PRK or LASIK procedure using the Summit Apex excimer laser. Attempted corrections ranged from 6.00 to 15.00 D. MAIN OUTCOME MEASURES: Data on uncorrected and spectacle-corrected visual acuity, predictability,and stability of refraction, corneal haze, and flap complications were analyzed. Patients were observed for up to 6 months. RESULTS: One day after surgery, 0 (0.0%) and 3 (4.5%) eyes in the PRK group saw 20/20 and 20/40 or better uncorrected, respectively, while 7 (10%) and 48 (68.6%) eyes in the LASIK group saw 20/20 and 20/40 or better, respectively. At 6 months after PRK, 13 (19.1%) and 45 (66.2%) eyes saw 20/20 and 20/40 or better, respectively, while after LASIK, 16 (26.2%) and 34 (55.7%) eyes saw 20/20 and 20/40 or better, respectively (odds ratio = 0.56 for likelihood of uncorrected visual acuity < 20/40 for PRK vs. LASIK, 95% confidence interval [CI] = 0.31-1.19). After PRK, 39 eyes (57.4%) were within 1.0 D of attempted correction compared with 24 eyes (40.7%) in the LASIK group (odds ratio = 0.50 for likelihood fo undercorrection 1.0 D for PRK vs. LASIK, 95% CI = 0.24-1.04); however, the standard deviation of the predictability was similar between groups: 1.01 D for PRK and 1.22 D for LASIK. From months 1 to 6, there was an average regression of 0.89 D in the PRK group and 0.55 D in the LASIK group. After PRK, eight eyes (11.8%) had a decrease in spectacle-corrected visual acuity of two Snellen lines or more; after LASIK, two eyes (3.2%) had a decrease of two lines or more (odds ratio = 3.89 for risk of loss of spectacle-corrected visual acuity for PRK vs. LASIK, 95% CI = 0.71-21.30). Only two eyes had postoperative spectacle-corrected visual acuity less than 20/32, however. CONCLUSIONS: Although improvement in uncorrected visual acuity is more rapid in LASIK than in PRK, efficacy outcomes in the longer term generally are similar between the two procedures. There is a greater tendency toward undercorrection in LASIK eyes using the specific laser and nomogram in this study, but the scatter in achieved versus attempted correction is similar, suggesting little difference in the accuracy of the two procedures. A suggestion of decreased propensity for loss of spectacle-corrected visual acuity in LASIK eyes requires further investigation.

The intrastromal corneal ring segments. Phase II results for the correction of myopia.

OBJECTIVE: The purpose of the study was to evaluate the safety and efficacy of the intrastromal corneal ring segments (ICRS) for the correction of myopia. DESIGN: A 2-year phase II clinical trial of ICRS was initiated in May 1995. The investigational plan specifies that 150 patients with sighted eyes, requiring myopic corrections from -1.00 to -6.00 diopters (D), will each receive ICRS in 1 eye. The patient population will be divided into approximately five patients per ICRS thickness (0.25, 0.30, 0.35, 0.40, and 0.45 mm) per site. Six investigational sites are participating in the trial. PARTICIPANTS: Fifty-nine men and 43 women requiring myopic corrections were enrolled at four U.S. investigational sites. These 102 patients each received the ICRS product in 1 eye. INTERVENTION: Correction of myopia. MAIN OUTCOME MEASURES: Efficacy of ICRS was assessed with respect to the trial endpoints of predictability of refractive effect, uncorrected visual acuity (UCVA), stability of UCVA, maintenance of best spectacle-corrected visual acuity and stability of refractive effect. RESULTS: As shown by the available month-3 data (99 patients; all device thicknesses), 95 (96%) of 99 patients had a UCVA of 20/40 or better. Ninety-eight (99%) of 99 patients were within 2 lines of their preoperative best spectacle-corrected visual acuity. The average change (with standard error) in cycloplegic refraction (spherical equivalent) achieved by ICRS thickness was -1.27 +/- 0.09 D (0.25 mm), -2.13 +/- 0.16 D (0.30 mm), -2.56 +/- 0.15 D (0.35 mm), -3.77 +/- 0.37 D (0.40 mm) and -4.16 +/- 0.24 D (0.45 mm). Seventy-seven percent (76/99) of the patients were within +/-1.00 D of their intended correction. When the ICRS was removed in two cases, both patients returned to within 0.75 D of their preoperative manifest refraction. CONCLUSIONS: The ICRS appears to be a viable and effective alternative for the treatment of myopia. Additionally, as indicated by the explant data, the ICRS's refractive effect may be reversible upon removal of the device.

Late onset of corneal scar after excimer laser photorefractive keratectomy.

PURPOSE: We studied the occurrence of late scarring after photorefractive keratectomy and its response to topical corticosteroids and debridement during the course of follow-up of 950 eyes that had photorefractive keratectomy with excimer laser. METHODS: Five eyes of four patients developed localized corneal scars, decreased visual acuity, and increased myopia after five to 33 months of good visual acuity, with trace haze. In two eyes, scars were removed by debridement alone. In these two eyes, recurrent scars were treated by debridement, followed by aggressive treatment with topical corticosteroids. Two other eyes were treated with topical corticosteroids alone. The fifth eye, which developed a scar after debridement to correct a subjective visual distortion after photorefractive keratectomy, was treated with debridement followed by aggressive topical corticosteroids. RESULTS: Treatment with topical corticosteroids alone in two eyes improved uncorrected visual acuity slightly and decreased myopia, although the scars remained unchanged. Debridement without aggressive topical corticosteroid use resulted in rapid return of the scars and a decrease in visual acuity. Subsequent debridement after aggressive topical corticosteroid treatment resulted in resolution of scars and no recurrence after discontinuation of corticosteroids in one case. In another case, the scar recurred eight months after discontinuation of topical corticosteroids. In Case 4, the scar has not recurred as the topical corticosteroid dosage has been reduced. CONCLUSIONS: Patients who undergo photorefractive keratectomy should be counseled concerning the risk of late scarring, reexamined frequently after photorefractive keratectomy, and treated with topical corticosteroids after corneal trauma. Long-term treatment with topical corticosteroids may be required to prevent the recurrence of scars after debridement.

Hydrogel intracorneal lenses in aphakic eyes.

BACKGROUND: The theoretical benefits of synthetic keratophakia over conventional corneal lamellar procedures are the elimination of donor concerns and superior refractive predictability. Additionally, synthetic material can be inspected for optical quality and power, and it can be sterilized. Furthermore, visual recovery should be more rapid since epithelium is not removed from the central part of the cornea and the need for keratocyte repopulation is eliminated. OBJECTIVE: To present results on patients who received an intracorneal implant (Kerato-Gel, Allergan Medical Optics, Irvine, Calif) that was made from lidofilcon A, a glucose-permeable hydrogel with an equilibrium water content of 68%. METHODS: The intracorneal implants were implanted in 35 adult patients for correction of aphakia. Inclusion criteria excluded patients with aphakia who were candidates for intraocular lenses. RESULTS: A total of 19 patients were followed up through 2 years postoperatively. For 16 patients with 2-year postoperative refractive data, the average spherical equivalent was -0.63 +/- 2.07 diopters (D). At 2 years, 88% of patients were within +/- 3.00 D of plano and 50% were within +/- 1.00 D. the mean change in Snellen's line for corrected visual acuity was -3.25 lines at 2 years for all patients and -2.0 lines for a subgroup of five patients who were free of vision-limiting preoperative disease. CONCLUSIONS: Results suggest that this intracorneal implant is well tolerated by the cornea and can provide predictable refractive results in patients with high-risk aphakia. Limitations of the procedure are uneven microkeratome resections, loss of best-corrected visual acuity, and irregular astigmatism in some patients. Although these data show good evidence of biocompatibility of the implant material, technical surgical progress is needed to advance this procedure into clinical therapeutic practice.

Classification of variable clinical response after photorefractive keratectomy for myopia.

BACKGROUND: Variation in healing response has been noted after excimer laser photorefractive keratectomy (PRK). METHODS: A retrospective analysis of 116 eyes that underwent PRK for myopia was performed. Standard surgical protocol and postoperative corticosteroid treatment were followed for all eyes. Scattergrams of achieved correction versus attempted correction at 6 months after surgery were analyzed. Subepithelial corneal haze was compared with refractive outcome. RESULTS: Three healing responses were observed. Normal responders (84.5%) showed a hyperopic overcorrection at 1 month with a gradual regression toward plano and good refractive outcome. Inadequate responders (11.2%) showed a pronounced early hyperopic overcorrection (greater than 1.50 diopters [D]) with minimal regression at 6 months. Aggressive responders (4.3%) displayed an early overcorrection with rapid regression toward myopia. Clear to trace subepithelial corneal haze was present at 6 months in 96% of normal and inadequate responders. Aggressive responders had more pronounced subepithelial haze at 6 months. CONCLUSION: Variation in the amount of subepithelial healing response occurs after excimer laser PRK. Abnormal healing responses may be detected early in the postoperative period by correlation of refractive error with the amount of subepithelial haze.

Photorefractive keratectomy for myopia using a 4.5-millimeter ablation zone.

BACKGROUND: Argon fluoride (193 nm) excimer laser photorefractive keratectomy for myopia is under evaluation by the United States Food and Drug Administration. METHODS: We report a consecutive prospective series of 100 patients (one eye per patient) treated as part of the Phase IIB FDA-approved protocol, with 80 patients followed for 1 year. Patients' ages ranged from 21 to 62 years (mean, 35 years). The Summit Technology, Inc ExciMed UV200LA with a 4.5-mm diameter ablation was used. RESULTS: Baseline spherical equivalent refraction ranged from -2.00 to -6.90 diopters (D) (mean -4.60 D). Ninety-five percent of eyes reepithelialized by 72 hours. At 1 year, the difference between attempted and achieved correction was +/- 0.50 D for 42 eyes (53%) and +/- 1.00 D for 60 eyes (75%). During the first 6 months, there was a trend toward overcorrection and the majority of eyes showed some loss of initial refractive correction; 10 eyes (14%) changed by 1.00 D or more between 6 and 12 months. An uncorrected visual acuity of 20/25 or better was achieved by 50 eyes (63%) and 20/40 or better by 61 eyes (77%). Of the 10 eyes (12%) that lost two or more Snellen lines of spectacle-corrected or glare visual acuity, two had visual acuity of worse than 20/25. Central subepithelial corneal haze was absent to mild in 77 (96%) eyes at 12 months. CONCLUSIONS: Excimer laser photorefractive keratectomy as performed in this study was generally effective and safe in reducing simple spherical myopia. Further studies of the effect of a larger diameter ablation zone, smoother transitional corneal contours, and the effect of postoperative topical corticosteroids may lead to further improvements in outcome.

Relation of visual symptoms to topographic ablation zone decentration after excimer laser photorefractive keratectomy.

BACKGROUND: The authors used computer-assisted videokeratoscopy to analyze the relation of photorefractive keratectomy ablation zone decentration to subjective patient assessments of disturbing visual symptoms. METHODS: Ablation zone decentration was measured 1 month postoperatively. The study population was divided into two groups: group 1, patients whose ablation zone decentrations were less than 0.50 mm; group 2, patients whose ablation zone decentrations were greater than 0.50 mm. Visual symptoms including glare, rings or halos around lights and problems with night driving were scored preoperatively and 6 months postoperatively. The Hotelling T-square and chi-square tests were used. RESULTS: The mean decentration from the center of the ablation zone to the pupillary center was 0.30 mm and 190 degrees for group 1 compared with 0.66 mm and 198 degrees for group 2. The Hotelling T-square test showed a significant statistical preoperative/postoperative difference in group 1 (P < 0.03) for the halo symptom category. No other symptom category showed a significant statistical difference in either group for the mean scores. The Hotelling T-square test did not show a statistically significant difference between the two groups preoperatively to postoperatively regarding the mean scores of the individual patient differences for the three symptoms. The only significant statistical difference for the individual patient ratings preoperatively to postoperatively was for the halo symptom category (chi-square = 7.756; P < 0.03). CONCLUSIONS: Multivariate analysis did not show a significant statistical difference preoperatively between the two groups or postoperatively except for group 1 with regard to the halo symptom category. It appears from this study that ablation zone decentrations less than 0.89 mm from the pupillary center do not necessarily produce unwanted visual symptoms 6 months postoperatively.