Terry E Burris

The Intrastromal Corneal Ring Segments: Phase II Results far 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 ICRSs refractive effect may be reversible upon removal of the device.

Optisol Corneal Storage Medium

Optisol is an investigational, intermediate-term corneal storage medium containing chondroitin sulfate and dextran to enhance corneal dehydration during storage. We used scanning electron microscopy to grade endothelial cell morphologic characteristics in terms of cell shape, cell borders, cell swelling, and apical holes in pairs of corneas stored in Optisol and Dexsol. Optisolstored corneas showed significantly fewer morphologic changes after 14 days at 4 degrees C than did Dexsol-stored corneas. No significant differences were seen after 1 to 4 days at 26 degrees C. Temperature-reversal analysis showed no significant change in corneal thickness with warming after 2-week storage at 4 degrees C in either medium, although Optisol-stored corneas were significantly thinner than those stored in Dexsol at all times. The results of scanning electron microscopy suggest that preservation at refrigerator temperature for 2 weeks in Optisol is superior to preservation in Dexsol. Both media may be useful in preserving endothelial structure for limited periods at room temperature, which could provide a measure of safety in shipping or storage where refrigeration is unreliable.

Flattening of central corneal curvature with Intrastromal Corneal Rings of increasing thickness: An eye-bank eye study

ABSTRACT Intrastromal Corneal Rings (ICRs) have been demonstrated to flatten human corneas when implanted into peripheral intrastromal corneal channels. To study the flattening effect, ICRs of increasing thickness, 0.26, 0.31, 0.36, 0.41, and 0.46 mm, were placed into oversized (approximately 70% depth) intrastromal channels in 38 eye‐bank eyes. Each of 33 eyes received one ICR; the mean change in dioptric data was obtained for four meridians using an intraoperative photokeratoscope. Intrastromal corneal rings of increasing thickness resulted in corneal flattening of 3.8 ± 1.1, 4.9 ± 0.6, 5.2 ± 1.1, 5.3 ± 1.9, and 7.3 ± 1.6 diopters, respectively, for keratoscope mire 2. One of each size ICR was placed into one of five additional eye‐bank eyes; the degree of flattening measured by laser holographic interferometry was 1.8, 2.9, 5.5, 4.7, and 10.1 diopters, respectively, for the central 6 mm corneal zone. These results indicate that the ICR provides a fairly linear flattening relationship over the range of thicknesses tested. Additionally, laser holographic interferometry wave unit maps of preoperative and postoperative corneas demonstrated that the ICR tends to preserve positive corneal asphericity if present preoperatively.

Intrastromal corneal ring : 12-month sighted myopic eyes

BACKGROUND To evaluate the efficacy, predictability, and stability of the refractive effect produced by the Intrastromal Corneal Ring (ICR), the authors completed a 12-month study on 10 myopic eyes. METHODS Ten patients with preoperative refractive errors ranging from -2.63 diopters (D) to -4.25 D (mean, -3.30 D) participated in the study. The attempted correction was -2.50 D for a 7.0-mm diameter, 0.3-mm thick ICR. One eye of each patient received an ICR. RESULTS The average change in spherical equivalent at 12 months was -2.25 D (SD 0.54 D; range, -1.62 to -3.25 D). All patients maintained a spectacle-corrected visual acuity of 20/20 or better during the 12-month study period, with the exception of patient no. 6 who saw 20/30 at the 6-month examination. Her spectacle-corrected visual acuity returned to 20/20 a few days after the ICR was explanted and remained stable throughout the study. Uncorrected visual acuity had improved to 20/40 or better in all patients on postoperative day 1 and remained in this range for the 9 eyes (90%) during the 12 months of follow up. At postoperative month 12, 9 of 9 eyes (100%) had an uncorrected visual acuity of 20/40 or better with 3 of 9 eyes (33%) seeing 20/20 or better. The remaining patient, no. 6, experienced a tear in Descemets membrane during the procedure and required explantation of the ring after 6 months due to induced astigmatism and deterioration of uncorrected visual acuity. Two patients developed infiltrates that resolved with the use of antibiotics. The most common postoperative ocular findings were peripheral corneal haze in all eyes that diminished over time, minute lamellar channel deposits (7 of 10 eyes, 70%), deep stromal neovascularization (5 of 10 eyes, 50%), and pannus (5 of 10 eyes, 50%). CONCLUSION This preliminary study shows that implantation of an intrastromal corneal ring of this dimension (0.3-mm thick) can reduce approximately 1.50 to 3.00 D of myopia and maintain spectacle-corrected visual acuity.

Effects of intrastromal corneal ring size and thickness on corneal flattening in human eyes.

Intrastromal corneal rings can flatten the human cornea, providing a potential new method of keratorefractive surgery. We investigated the effect of implanting various ring sizes of a given thickness in 8.50-mm intrastromal channels dissected in human eye bank corneas. A new intraoperative corneal topography device was used to obtain serial data. Smaller rings with no expansion pressure on the channels were found to induce corneal flattening presumably due to the ring thickness alone. Rings of increasing diameters produced high degrees of corneal flattening at progressively declining rates; this suggests that shear stresses may have expanded the channel due to mechanical stresses placed by our particular experimental technique. Implantation techniques that minimize stress on the outer channel lamellae appear advisable. New ring designs should take ring thickness into consideration along with outer edge configurations that minimize shear stresses on the lamellar channels.

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.

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.

Intrastromal 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.

Lamellar intrastromal corneal tattoo for treating iris defects (artificial iris)

PURPOSE Defects in the iris are associated with clinically significant optical anomalies, such as glare and peripheral light scatter; however, current artificial-iris technology remains inadequate. The purpose of this study was to explore the practicality of a lamellar intrastromal tattoo technique as a treatment modality to correct optical and cosmetic defects resulting from simulated iris abnormalities in eye-bank eyes. METHODS Simulated iris defects (abnormally large pupil, sector iridectomy, iridodialysis, and aniridia) were produced in a series of eye-bank eyes. Depending on the simulated iris defect, one or two lamellar channel(s) were created at 50% depth of the cornea via a peripheral incision (1.8 mm) with specialized proprietary instruments (KeraVision, Inc., Fremont, CA, U.S.A.). Commercially available tattoo pigment was inserted through the lamellar channel(s) and blended into the defective region of the iris. RESULTS The tattoo treatment was relatively simple to perform. Tattoo pigment was inserted uniformly through the small incision, and adequate color blending to match the recipient iris was achieved. The intrastromal tattoo effectively obscured light. CONCLUSION The lamellar intrastromal tattoo technique appeared to be efficacious for treating different types of iris defects in eye-bank eyes. Further investigation of this technique in nonsighted patient eyes is warranted.

Corneal asphericity in eye bank eyes implanted with the intrastromal corneal ring

OBJECTIVE To evaluate the effects of the intrastromal corneal ring, a device developed to reduce myopia, on corneal asphericity in a large set of eye bank eyes. METHODS Forty-one deturgesced eye bank eyes were implanted with intrastromal corneal rings of five different thicknesses, ranging from 0.25 mm to 0.45 mm. Corneal asphericity, before and after implantation, was examined using two different metrologies. Corneal asphericity profiles were produced from dioptric power data collected from videokeratography. To statistically assess the corneal asphericity differences between exam times for each intrastromal corneal ring thickness, dependent sample confidence intervals (95%) were calculated for the mean differences between preoperative and postoperative measures for each topographic diameter zone. Laser holographic interferometry was used to inspect corneal asphericity in one eye bank eye case study for four intrastromal corneal ring sizes. Wave unit map and geometric zonal spot ray tracing analyses derived from laser holographic interferometry topography were surveyed. RESULTS Videokeratographic analysis suggested that preoperative corneal shape was prolate, i.e., flattened from central to paracentral cornea. Corneal shape became more prolate with intrastromal corneal ring implantation for all intrastromal corneal ring thicknesses. Laser holographic interferometry demonstrated that prolate asphericity was preserved with the intrastromal corneal ring sizes tested and that optical collection efficiency of the cornea was not diminished. CONCLUSION Using two different measurement techniques, this eye bank eye study demonstrated that intrastromal corneal rings maintain prolate corneal asphericity.