Phase IV Multicenter, Prospective, Open-Label Clinical Trial of Cenegermin (rhNGF) for Stage 1 Neurotrophic Keratopathy (DEFENDO).

INTRODUCTION: Cenegermin is approved for treatment of neurotrophic keratopathy (NK) and has been studied in patients with stage 2 or 3 NK. This study evaluated the efficacy and safety of cenegermin in adults with stage 1 NK. METHODS: This was a phase IV, multicenter, prospective, open-label, uncontrolled trial. Adults with stage 1 NK (Mackie criteria) and decreased corneal sensitivity (≤ 4 cm) received 1 drop of cenegermin 20 mcg/ml in the affected eye(s) 6 times/day for 8 weeks with a 24-week follow-up. RESULTS: Of 37 patients, corneal epithelial healing was observed in 84.8% (95% confidence interval [CI] 68.1-94.9%; P < 0.001) at week 8; 95.2% (95% CI 76.2-99.9%; P < 0.001) of those patients remained healed at the end of the 24-week follow-up (week 32). At week 8, 91.2% (95% CI 76.3-98.1%; P < 0.001) of patients experienced improved corneal sensitivity; this improvement was observed in 82.1% (95% CI 63.1-93.9%; P < 0.001) of patients at week 32. Mean best-corrected distance visual acuity change from baseline at week 8 was - 0.10 logMAR (standard deviation [SD], 0.15; 95% CI - 0.16 to - 0.05; P < 0.001) and at week 32 was - 0.05 logMAR (SD, 0.16; 95% CI - 0.11 to 0.01; P = 0.122). At weeks 8 and 32, 15.2% (95% CI 5.1-31.9%; P < 0.001) and 10.7% (95% CI 2.3-28.2%; P < 0.001) of patients, respectively, had a 15-letter gain from baseline. At least one adverse event (AE) was reported by 73.0% and 45.7% of patients during the treatment and follow-up periods, respectively. The most common treatment-related, treatment-emergent AEs were eye pain (37.8%), blurred vision (10.8%), and eyelid pain (8.1%); these were mostly mild or moderate and were only reported during the treatment period. CONCLUSIONS: These results support the potential use of cenegermin for treating patients with stage 1 NK, and future confirmatory studies would be beneficial to elaborate on these findings. TRIAL REGISTRATION: DEFENDO; NCT04485546.

Efficacy of the Systane iLux Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction After 1 Week and 1 Month: A Prospective Study.

OBJECTIVES: To assess 1-week and 1-month efficacy of Systane iLux thermal pulsation treatment for meibomian gland dysfunction (MGD). METHODS: This prospective, nonrandomized, open-label, multicenter study enrolled 30 adult patients (60 eyes) who had a Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire score greater than 6 and total meibomian gland secretion (MGS) score equal to or less than 12 in each eye. All participants received thermal pulsation treatment bilaterally. Primary efficacy measures included MGS score (sum of grades for 15 glands graded on a scale of 0-3; 0 [no secretion], 1 [inspissated], 2 [cloudy], and 3 [clear liquid]) and tear breakup time (TBUT). Secondary efficacy measures were SPEED and Ocular Surface Disease Index (OSDI) scores. RESULTS: The mean age of patients was 52.9±11.9 years. After 1 week, the mean MGS score improved significantly from 4.1±3.1 to 15.8±7.1 (right eye, OD) and 3.7±3.1 to 16.7±7.6 (left eye, OS); mean TBUT improved significantly from 4.9±4.1 to 8.4±3.6 (OD) and 5.2±4.2 to 8.9±3.9 (OS); and mean SPEED and OSDI scores improved significantly from 16.1±5.3 to 7.2±6.1 and 45.2±21.3 to 19.0±16.8, respectively (all P<0.001). After 1 month, the mean MGS score improved to 18.3±8.2 (OD) and 18.6±7.3 (OS); mean TBUT improved to 9.7±3.8 (OD) and 9.6±3.5 (OS); and mean SPEED and OSDI scores improved to 7.0±5.6 and 16.7±14.5, respectively (all P<0.001). No adverse events were reported. CONCLUSIONS: Systane iLux thermal pulsation treatment for MGD resulted in a statistically significant increase in meibomian gland secretion, improvement in tear film stability, and reduction in dry eye symptoms as early as both 1 week and 1 month.

Usefulness of refractive measurement of wavefront autorefraction in patients with difficult retinoscopy.

PURPOSE: To assess the ability of the WaveScan WaveFront System (VISX Inc, Santa Clara, CA) to measure refractive errors in patients with difficult retinoscopy and to compare results to standard cycloplegic retinoscopy. METHODS: The medical records of patients with an ocular condition that could contribute to difficult or unreliable retinoscopy who underwent nondilated, noncycloplegic evaluation with the WaveScan WaveFront System were reviewed retrospectively. Results were compared to a standard cycloplegic retinoscopy. RESULTS: A total of 60 eyes of 31 patients were included. Wavefront sphere, cylinder, and spherical equivalent measurements were strongly correlated with retinoscopy results; however, the wavefront measured more myopia and more cylinder compared to standard retinoscopy. CONCLUSIONS: Wavefront can be used to augment and enhance cycloplegic streak retinoscopy.

Intraocular lens calculation adjustment after laser refractive surgery using Scheimpflug imaging.

PURPOSE: To test a new method of intraocular lens (IOL) calculation after corneal refractive surgery using Scheimpflug imaging (Pentacam HR) and partial coherence interferometry (PCI) (IOLMaster) that does not require historical data; that is, the Schuster/Schanzlin-Thomas-Purcell (SToP) IOL calculator. SETTING: Shiley Eye Center, San Diego, California, and Walter Reed National Military Medical Center, Bethesda, Maryland, USA. DESIGN: Retrospective data analysis and validation study. METHODS: Data were retrospectively collected from patient charts including data from Scheimpflug imaging and refractive history. Target refraction was calculated using PCI and the Holladay 1 and SRK/T formulas. Regression analysis was performed to explain the deviation of the target refraction, taking into account the following influencing factors: ratio of posterior-to-anterior corneal radius, axial length (AL), and anterior corneal radius. RESULTS: The regression analysis study included 61 eyes (39 patients) that had laser in situ keratomileusis (57 eyes) or photorefractive keratectomy (4 eyes) and subsequent cataract. Two factors were found that explained the deviation of the target refraction using the Holladay 1 formula; that is, the ratio of the corneal radii and the AL and the ratio of corneal radii for the SRK/T formula. A new IOL adjustment calculator was derived and validated at a second center using 14 eyes (10 patients). CONCLUSIONS: The error in IOL calculation for normal eyes after laser refractive treatment was related to the ratio of posterior-to-anterior corneal radius. A formula requiring Scheimpflug data and suggested IOL power only yielded an improved postoperative result for patients with previous corneal laser refractive surgery having cataract surgery. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

An optomechanical model eye for ophthalmological refractive studies.

PURPOSE: To create an accurate, low-cost optomechanical model eye for investigation of refractive errors in clinical and basic research studies. METHODS: An optomechanical fluid-filled eye model with dimensions consistent with the human eye was designed and fabricated. Optical simulations were performed on the optomechanical eye model, and the quantified resolution and refractive errors were compared with the widely used Navarro eye model using the ray-tracing software ZEMAX (Radiant Zemax, Redmond, WA). The resolution of the physical optomechanical eye model was then quantified with a complementary metal-oxide semiconductor imager using the image resolution software SFR Plus (Imatest, Boulder, CO). Refractive, manufacturing, and assembling errors were also assessed. A refractive intraocular lens (IOL) and a diffractive IOL were added to the optomechanical eye model for tests and analyses of a 1951 U.S. Air Force target chart. RESULTS: Resolution and aberrations of the optomechanical eye model and the Navarro eye model were qualitatively similar in ZEMAX simulations. Experimental testing found that the optomechanical eye model reproduced properties pertinent to human eyes, including resolution better than 20/20 visual acuity and a decrease in resolution as the field of view increased in size. The IOLs were also integrated into the optomechanical eye model to image objects at distances of 15, 10, and 3 feet, and they indicated a resolution of 22.8 cycles per degree at 15 feet. CONCLUSIONS: A life-sized optomechanical eye model with the flexibility to be patient-specific was designed and constructed. The model had the resolution of a healthy human eye and recreated normal refractive errors. This model may be useful in the evaluation of IOLs for cataract surgery.

Epithelial healing and visual outcomes of patients using omega-3 oral nutritional supplements before and after photorefractive keratectomy: a pilot study.

PURPOSE: To investigate the effect of omega-3 oral nutritional supplementation on corneal reepithelialization, visual acuity, and tear stability after photorefractive keratectomy (PRK). METHODS: This is a prospective, randomized, single-blinded controlled therapeutic trial using omega-3 oral nutritional supplements (TheraTears Nutrition for Dry Eyes; Advanced Vision Research-Akorn, Ann Arbor, MI) conducted at our center. Eighteen healthy patients with refractive error between -1 and -8 diopters were recruited and had bilateral PRK. The treatment group (n = 9 subjects) received omega-3 2 weeks before surgery through 1 month after PRK. The control group (n = 9 subjects) was not given omega-3. Epithelial defects were photographed on postoperative days 0 to 5. Reepithelialization (area in square millimeters) was assessed by fluorescein staining until healing. Tear breakup time (TBUT) and uncorrected distance visual acuity were measured at 1 week, and 1 and 3 months postoperatively. RESULTS: Epithelial defect in the treatment group eyes healed faster compared with that of the controls (P = 0.04). The treatment group eyes healed at an average rate of 1.19% [SD = 0.002; 95% confidence interval (CI), 1.04%-1.34%] per hour, versus 0.83% (SD = 0.0008; 95% CI, 0.77%-0.89%) for controls (Mann-Whitney rank-sum test, P < 0.001). The treatment group eyes maintained a significantly longer TBUT from week 1 through 3 months (mean = 9.52 seconds, SD = 0.81; 95% CI, 8.93-10.10), compared with the controls (mean = 5.52 seconds, SD = 0.81; 95% CI, 4.93-6.10; P < 0.001), and all reached 20/20 vision versus only 4 in the control group 1 month after surgery (P = 0.03). CONCLUSIONS: Omega-3 oral nutritional supplements decreased the average time for epithelial healing, and improved TBUT and visual acuity recovery in PRK. These findings suggested that omega-3 oral nutritional supplementation may be a beneficial adjunct therapy for PRK patients.

Corneal asphericity and spherical aberration after refractive surgery.

PURPOSE: To evaluate changes in corneal asphericity (Q) and spherical aberrations after refractive surgery using Scheimpflug imaging. SETTING: University of California, San Diego, Shiley Eye Center, La Jolla, California, USA. DESIGN: Cohort study. METHODS: After wavefront-guided laser in situ keratomileusis, patients within ± 0.50 diopter of plano and with an uncorrected distance visual acuity of at least 20/20 were evaluated. The Q values and corneal spherical aberration Zernike values were obtained using Scheimpflug imaging preoperatively and 1 to 3 months postoperatively. RESULTS: The study enrolled 177 myopic eyes and 32 hyperopic eyes. The mean Q value was -0.28 ± 0.11 (SD) and -0.22 ± 0.15, respectively, preoperatively and +0.35 ± 0.44 and -0.64 ± 0.31, respectively, postoperatively. The asphericity change was highly correlated with preoperative spherical equivalent (r(2) = 0.81; P ≤ .001). The mean corneal spherical aberration was +0.21 ± 0.08 µm in myopic eyes and +0.36 ± 0.11 µm in hyperopic eyes preoperatively and +0.36 ± 0.17 µm and 0.00 ± 0.29 µm, respectively, postoperatively. The corneal spherical aberration changes were correlated with the amount of preoperative refractive error (r(2) = 0.34; P < .001). There was a tendency for Q values and spherical aberrations to become more positive after myopic ablation and more negative after hyperopic ablation. CONCLUSIONS: Myopic and hyperopic corrections induced changes in the Q value and spherical aberrations in opposite directions (ie, positive and negative, respectively). The changes depended on the magnitude of the refractive correction. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Gabapentin for postoperative pain after photorefractive keratectomy: a prospective, randomized, double-blind, placebo-controlled trial.

PURPOSE: To determine whether treatment with oral gabapentin reduces postoperative pain after photorefractive keratectomy (PRK). METHODS: This prospective, randomized, double-blind, placebo-controlled study comprised 40 patients scheduled for bilateral PRK. Exclusion criteria were previous refractive surgery; diseases that could affect epithelial healing; use of antihistamines, nonsteroidal anti-inflammatory drugs, or steroids; and use of mitomycin C during PRK. Patients were divided into two groups: 20 patients received gabapentin capsules (300 mg) and 20 patients received identical placebo capsules. Visual acuity, slit-lamp examination, and a 12-question, 10-point visual numerical scale questionnaire were evaluated at each postoperative follow-up. Main outcome measures were the severity of pain at each follow-up and during the previous 24 hours. Secondary outcome measures were maximum and minimum severity of pain, healing time, uncorrected distance visual acuity, and the rating of other symptoms and potential side effects. RESULTS: The gabapentin group had less pain during the first 72 hours (P=.024 to .001). A significant difference in favor of gabapentin was found for the first 48 hours regarding minimum pain severity (P=.005 and .01 for 24 and 48 hours, respectively) and for the first 72 hours for maximum pain severity (P=.014, .007, and .001 for 24, 48, and 72 hours, respectively). No significant differences were observed for side effects, symptoms, or healing time except discomfort in favor of gabapentin during the first 24 hours (P=.043). CONCLUSIONS: Gabapentin significantly reduced postoperative pain after PRK compared to placebo, with no increase in reported side effects.

Delayed diagnosis of microsporidial stromal keratitis: unusual Wessely ring presentation and partial treatment with medications against Acanthamoeba.

The authors report a case of an immunocompetent 38-year-old male who presented with an indolent keratitis that eluded diagnosis after multiple cultures taken over 9 months. He was started initially on medications against Acanthamoeba, after presenting with a nearly complete corneal ring 2 months after trauma. These medications likely partially treated his condition, thereby making laboratory diagnosis more difficult. He was identified as having Encephalitozoon hellum by PCR. The patient subsequently underwent cornea transplant after a full course of medical treatment and recovered best-corrected visual acuity of 20/20.

A modified deep anterior lamellar keratoplasty using intacs dissectors.

PURPOSE: To describe a new technique for deep anterior lamellar keratoplasty in the human eye. METHODS: We obtained globes from the San Diego Eye Bank and performed central and peripheral pachymetry measurements at the 8-mm optical zone. We made a radial incision at the edge of the optical zone at 90% depth of central corneal thickness. We enlarged the incision and started lamellar dissection. The curved tunnel was created using dissecting instruments (Addition Technology, Des Plaines, IL), used in Intacs channels. With a sweeping motion, we connected these channels. An 8-mm Barron Radial Vacuum Trephine (Baron Precision Instruments, LLC, Grand Blanc, MI) was placed over the optical zone until the 90% depth of thickness was reached. The cap tissue was detached and viscoelastic was used to separate Descemet membrane and stromal tissue. We photographed the surface for analysis. RESULTS: This technique was easy to perform with little remaining posterior stromal tissue. Residual tissue could easily be dissected, and the vacuum trephine could easily reach the same depth of the pocket. The outer edge of the bed had a clean sharp edge. The stromal bed surface and the inner corneal cap were smooth. CONCLUSIONS: We conclude that this modified technique is easy to perform and results in a more regular stromal surface. This technique may reduce the need for penetrating keratoplasty.

Visual outcomes after wavefront-guided laser in situ keratomileusis with and without iris registration.

PURPOSE: To compare the clinical outcomes of wavefront-guided laser in situ keratomileusis in eyes in which iris registration was used (IR group) and eyes in which iris registration would not engage (no-IR group). SETTING: Shiley Eye Center, University of California San Diego, La Jolla, California, USA. METHODS: This retrospective analysis comprised 112 eyes of 64 patients who had wavefront-guided LASIK using the Visx CustomVue S4 IR platform (Advanced Medical Optics) for myopia or myopic astigmatism. The safety, efficacy, predictability, and need for enhancement at the 3-month follow-up were evaluated and compared between the IR group and the no-IR group. RESULTS: By 3 months postoperatively, all eyes in the IR group and 93% of eyes in the no-IR group had the same best spectacle-corrected visual acuity (BSCVA) as preoperatively or had gained 1 to 2 lines of BSCVA. No eye in either group lost more than 1 line of BSCVA (P = 0.12). Ninety-six percent of eyes in the IR group and 93% in the no-IR group were within +/-0.50 diopter (D) of the postoperative manifest refraction spherical equivalent (P = 0.24), and all eyes were within +/-1.00 D of emmetropia. Four eyes in the IR group and 11 in the no-IR group required retreatment during the follow-up period (P = 0.1). CONCLUSION: The results in the IR group and the no-IR group were comparable, with no statistically significant differences in measured outcomes.

Wavefront-guided laser in situ keratomileusis in the treatment of high myopia by using the CustomVue wavefront platform.

PURPOSE: To assess the efficacy, predictability, and safety of wavefront-guided laser in situ keratomileusis (LASIK) in the treatment of high myopia by using the Visx S4 CustomVue wavefront platform. METHODS: A retrospective analysis of consecutive cases of eyes with high myopia (manifest refraction spherical equivalent >or= -6.00 D) that underwent non-physician-adjusted wavefront-guided LASIK by using the Visx S4 CustomVue wavefront platform. Forty-three eyes of 29 patients were included. Preoperative best spectacle-corrected visual acuity (BSCVA), manifest refraction, WaveScan refraction, postoperative uncorrected visual acuity (UCVA) and BSCVA, and manifest refraction were determined. The clinical outcomes were evaluated on the basis of standard formats and criteria. Data at 3 months postoperatively are presented. RESULTS: Preoperatively, we found mean sphere was -6.89 +/- 1.08 D, mean cylinder was -0.97 +/- 0.75 D, and mean spherical equivalent (SE) was -7.38 +/- 1.20 D. Postoperatively, mean sphere was 0.02 +/- 0.40 D, mean cylinder was -0.40 +/- 0.40 D, and mean SE was -0.18 +/- 0.43 D. UCVA was 20/15 or better in 27.9% and cumulatively 20/20 or better in 58% of eyes. All eyes treated had at least 20/50 UCVA. Efficacy index was 0.94. Eighty-two percent of eyes were within 0.50 D and 97.6% were within 1.00 D of emmetropia at the 3-month follow-up visit. Ninety-one percent of eyes either maintained or gained 1 line of BSCVA. No eye lost >1 line of BSCVA. The safety index was 1.1. CONCLUSIONS: The 3-month follow-up results of our study indicate that wavefront-guided LASIK by using the Visx S4 CustomVue wavefront platform is an effective, predictable, and safe treatment of high myopia.

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.

The effect of cyclosporine A (Restasis) on recovery of visual acuity following LASIK.

PURPOSE: To compare the recovery of uncorrected visual acuity (UCVA) following LASIK in patients treated with topical cyclosporine A 0.05% and patients treated with a standard postoperative regimen. METHODS: In this single-center, open-label, retrospective study, a standard refractive workup was performed in 45 patients (85 eyes) who underwent LASIK and did not have preexisting dry eye. In 36 eyes, a standard postoperative eye drop regimen was followed, and in 49 eyes, cyclosporine A 0.05% was added to the standard regimen for 12 weeks. Uncorrected visual acuity was measured 1 week and 1 and 3 months postoperatively. RESULTS: One week postoperatively, 22 (44.9%) eyes in the cyclosporine A group and 8 (22.2%) eyes in the standard treatment group had UCVA of 20/15. Cumulatively, 36 (73.5%) eyes in the cyclosporine A group and 24 (66.7%) eyes in the standard treatment group had UCVA of 20/20 or better. One month postoperatively, 37 (75.5%) in the cyclosporine A group and 23 (63.9%) eyes in the standard treatment group had UCVA of 20/20 or better. Three months postoperatively, 40 (81.6%) eyes in the cyclosporine A group and 25 (69.4%) eyes in the standard treatment group had UCVA of 20/20 or better. Mean UCVA in the cyclosporine A group showed statistically significant improvements compared with the standard treatment group. CONCLUSIONS: Cyclosporine A 0.05%, in the form of Restasis, may be an effective treatment for reducing the time needed for visual recovery after LASIK. Use of cyclosporine A was associated with overall better and faster recovery of UCVA.

Blepharoplasty in the post-laser in situ keratomileusis patient: preoperative considerations to avoid dry eye syndrome.

BACKGROUND: The authors used a retrospective case series to describe the increased frequency of dry eye syndrome in patients who have undergone both laser in situ keratomileusis and blepharoplasty. METHODS: The authors reviewed records from six patients who required surgical correction for exposure keratopathy previously treated by both laser in situ keratomileusis and blepharoplasty. RESULTS: All six patients developed significant exposure keratopathy postoperatively requiring surgical intervention. Four patients had blepharoplasty followed by laser in situ keratomileusis, and two patients had laser in situ keratomileusis followed by blepharoplasty. Symptomatic dry eye symptoms followed the second procedure 1 week to 4 months later. Surgical correction of eyelid malposition and lagophthalmos markedly improved symptoms. CONCLUSIONS: Patients with a history of laser in situ keratomileusis contemplating blepharoplasty are at higher risk of developing postoperative dry eye syndrome. Surgeons performing these procedures should perform thorough preoperative evaluation and surgical planning to minimize this potential complication.

Early postoperative pain following Epi-LASIK and photorefractive keratectomy: a prospective, comparative, bilateral study.

PURPOSE: To compare postoperative pain associated with epi-LASIK versus photorefractive keratectomy (PRK). METHODS: This prospective observer-masked randomized study included 40 eyes of 20 patients with myopia and astigmatism who received epi-LASIK (Moria Epi-K) in one eye and PRK in the contralateral eye. Corneal ablation was done using the NIDEK EC-5000 excimer laser. Patients were seen at days 1, 3, and 6 to rate their pain via three measuring tools: 1) a global subjective rating, 2) a 10-cm visual analog scale, and 3) an 11-point numeric scale of pain. RESULTS: On postoperative day 1, 19 of 20 patients reported pain in both eyes. Using the global subjective rating scale, patients reported more pain for those eyes treated by PRK. Although clinically relevant, this difference was not statistically significant (P = .56). Based on the 11-point numeric scale of pain and visual analog scale, mean pain scores were similar for both groups. On day 3, using the global subjective rating scale, 11 of 12 patients who had pain reported more in the epi-LASIK treated eye (P = .0005). In addition, epi-LASIK eyes demonstrated higher mean pain scores based on the other two scales (visual analog scale, P = .045 and 11-point numeric scale of pain, P = .023). Only 6 patients reported minimal pain on day 6. It was more frequently reported and slightly more marked in epi-LASIK eyes, but did not reach statistical significance. CONCLUSIONS: Epi-LASIK and PRK have similar pain on postoperative day 1, but epi-LASIK demonstrated statistically more pain than PRK on days 3 and 6.

In vivo architectural analysis of 3.2 mm clear corneal incisions for phacoemulsification using optical coherence tomography.

PURPOSE: To analyze in vivo the architecture of clear corneal incisions (CCIs) for phacoemulsification using optical coherence tomography (OCT). SETTING: Anterior Segment Department, Asociacion Para Evitar la Ceguera en Mexico, Hospital Dr Luis Sanchez Bulnes, Mexico. METHODS: A prospective masked study analyzed 20 unsutured CCIs placed superiorly and created in a uniplanar fashion with a 3.2 mm slit-angled metal keratome. All wounds were evaluated with a retinal OCT model 1, 3, and 30 days postoperatively. Intraocular pressure (IOP) and incision leakage were checked. The architecture was described according to the angle of incidence, apposition of the epithelial and endothelial margins, and wound sealing. RESULTS: No leakage was detected. The angle varied from 33 to 85 degrees; angles greater than 75 degrees were done by a surgeon in training. Wound apposition at the epithelial margin was achieved in all cases. In contrast, imperfect apposition of the endothelial margin was seen in 45% of incisions on day 1 and in 15% on day 30. Incomplete sealing of the wound was seen by OCT in 25% of cases at 24 hours and persisted in 10% of all cases at 1 month. This gaping occurred on the endothelial side and never translated to the epithelial margin. No statistical correlation was found between gaping and the angle of the incision, IOP variations, or surgeon experience. CONCLUSIONS: Although in vivo CCIs caused minor anatomic imperfections, they were clinically stable independent of incision angle, IOP variation, and surgeon experience. Incision stability may be related to careful wound construction, epithelial viability, stromal edema, and efficient endothelial pumping.

Eye banking error: report of a donor cornea with a soft contact lens left in place.

PURPOSE: To report the first known case of a donor cornea being examined and shipped with a soft contact lens in place. METHODS: Case Report. RESULTS: Surgery was cancelled, the two involved eye-banks were notified, and the patient underwent successful keratoplasty 2 days later. CONCLUSION: Eye banking is essential to the practice of Ophthalmology. Rarely, errors occur despite the strict protocols and procedures that have been instituted over the years. These errors force us to reevaluate and update those policies as technology rapidly advances. We present here the first reported case of donor ocular tissue being examined and then shipped with a contact lens on the cornea. It is possible that there are other errors that are not published. It behooves us to disclose these and to discuss any of these errors openly to allow us to maintain confidence in our local eye banks, and to help us practice the safest medicine possible for our patients.