Glucose challenge test screening for prediabetes and undiagnosed diabetes.

AIMS/HYPOTHESIS: Diabetes prevention and care are limited by lack of screening. We hypothesised that screening could be done with a strategy similar to that used near-universally for gestational diabetes, i.e. a 50 g oral glucose challenge test (GCT) performed at any time of day, regardless of meal status, with one 1 h sample. METHODS: At a first visit, participants had random plasma and capillary glucose measured, followed by the GCT with plasma and capillary glucose (GCTplasma and GCTcap, respectively). At a second visit, participants had HbA(1c) measured and a diagnostic 75 g OGTT. RESULTS: The 1,573 participants had mean age of 48 years, BMI 30.3 kg/m(2) and 58% were women and 58% were black. Diabetes (defined by WHO) was present in 4.6% and prediabetes (defined as impaired glucose tolerance [2 h glucose 7.8-11.1 (140-199 mg/dl) with fasting glucose

A prospective multicenter clinical trial to evaluate the safety and effectiveness of the implantable miniature telescope.

PURPOSE: To evaluate the safety and preliminary efficacy of a novel visual prosthetic device, the Implantable Miniature Telescope, IMT (by Dr Isaac Lipshitz) (IMT), in a phase I trial in patients with significant bilateral central vision impairment from late-stage age-related macular degeneration (AMD). The IMT is designed to reduce the relative size of the scotoma by rendering enlarged (threefold) central visual field images over the central and peripheral retina. DESIGN: Prospective, multicenter, open-label clinical trial. METHODS: In this prospective, multicenter phase I trial, 14 patients aged 60 or older with bilateral geographic atrophy or disciform scar AMD, cataract, and best-corrected visual acuity (BCVA) between 20/80 and 20/400 had an IMT implanted in one eye. Distance and near BCVA, endothelial cell density, and quality of life, measured as activities of daily life (ADL), were evaluated preoperatively and postoperatively. RESULTS: At 12 months, 10 (77%) of 13 patients gained 2 more lines of either distance or near BCVA, and eight (62%) of 13 patients gained 3 or more lines in either distance or near BCVA. Mean endothelial cell density decreased by 13%. All adverse events resolved without sequelae. ADL scores improved in the majority of patients. CONCLUSION: The results of this phase I trial support further evaluation of the IMT in a larger study population with late-stage AMD. A phase II/III trial is in progress.

Intrastromal corneal ring segments for low myopia: a report by the American Academy of Ophthalmology.

OBJECTIVE: This document describes intrastromal corneal ring segments (Intacs) inserts technology and examines the evidence to answer the key question about whether the treatment is safe and effective in correcting low myopia. METHODS: A literature search that was conducted in September 2000 retrieved 13 relevant citations, and the reference lists of these articles were consulted for additional citations. Panel members reviewed this information and articles were rated according to the strength of evidence. RESULTS: Prospective multicenter phase II and III clinical trials (Level II evidence rating) of Intacs inserts for myopia of -1.00 to -3.00 diopters (D), with a maximum of +1.00 D of astigmatism, enrolled a total of 452 subjects, with a total of 454 surgical attempts. The results from phase II and phase III were pooled for much of the analysis. At 1 year, 97% of patients who completed follow-up had 20/40 or better uncorrected visual acuity (UCVA). Seventy-four percent of patients had 20/20 or better UCVA. Ninety-two percent of eyes were within +/-1 D of intended refractive correction, and 69% were within 0.5 D of intended refractive correction. At 3 months, 90% of patients had less than 1.0 D of change from the previous examination performed at 1 month. The ocular complication rate, which was defined as clinically significant events but not resulting in permanent sequelae, was 11% at 12 months. The adverse event rate was 1.1%, defined as a serious event if untreated. Nearly 9% of patients requested to have their inserts removed and a total of 3.8% of patients required a secondary surgical intervention. CONCLUSIONS: To date, evidence suggests that low myopia (-1 to -3 D) in a well-defined group of patients who have a stable manifest refraction and less than +1.0 D of astigmatism can be treated with Intacs inserts with a reasonable assurance of safety and effectiveness. Additional clinical research is needed to determine the long-term effectiveness of treatment and the comparative safety, effectiveness, and costs with other treatment modalities, including laser-assisted in-situ keratomileusis (LASIK) and photorefractive keratectomy (PRK).

Optic neuropathy associated with laser in situ keratomileusis.

PURPOSE: To report 4 cases of optic neuropathy following laser in situ keratomileusis (LASIK). SETTING: Tertiary Care ophthalmic practices. METHODS: In this retrospective observational case series, 4 patients who developed acute visual loss following LASIK are reported. All had clinical evidence of optic neuropathy. Two had optic disc edema and 2 had normal appearing optic discs initially. None of the patients experienced significant visual recovery, and all developed optic atrophy in the affected eye. RESULTS: All patients had evaluations for alternative etiologies of their optic neuropathy, with negative results. All patients were therefore presumed to have experienced an ischemic optic neuropathy following LASIK. CONCLUSIONS: Patients who have LASIK may experience an acute anterior or retrobulbar optic neuropathy. The etiology is unknown but may be related to the marked increase in intraocular pressure that occurs during a portion of the procedure.

Diffuse lamellar keratitis associated with epithelial defects after laser in situ keratomileusis.

PURPOSE: To describe the association between the presence of epithelial defects and the development of diffuse lamellar keratitis (DLK), "Sands of the Sahara" syndrome, following laser in situ keratomileusis (LASIK). SETTING: Cullen Eye Institute, Department of Ophthalmology, Baylor College of Medicine, Houston, Texas, USA. METHODS: In this retrospective study, the postoperative clinical course and surgical outcomes in 735 eyes of 358 consecutive patients who had myopic LASIK between December 1998 and August 1999 were reviewed. Of the 735 procedures, 680 were primary LASIK procedures and 55 were retreatments performed by lifting the existing flaps. The incidence and severity of DLK and the relationship of DLK to epithelial defects were tabulated. RESULTS: Diffuse lamellar keratitis developed in 9 of the 16 eyes that had postoperative epithelial defects. Seventeen eyes without epithelial defects also developed DLK. The presence of an epithelial defect increased an individual's risk of developing DLK 24 times (95% confidence interval, 13 to 45). In 8 eyes, the inflammation resolved following treatment with intense topical corticosteroids. One eye had irrigation under the flap because of dense central inflammation; the final outcome was mild inferior corneal steepening. All eyes recovered preoperative best spectacle-corrected visual acuities. CONCLUSION: Patients who have epithelial defects of any size following LASIK are at significantly increased risk of developing DLK.

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.

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

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

Ocular biocompatibility testing of intraocular lenses: a 1 year study in pseudophakic rabbit eyes.

PURPOSE: To evaluate the appropriate duration for conducting ocular biocompatibility studies with an intraocular lens (IOL) in the pseudophakic rabbit model. SETTING: Alcon Laboratories, Inc., Fort Worth, Texas, USA. METHODS: A single-piece biconvex poly(methyl methacrylate) (PMMA) IOL was implanted in the capsular bag of 18 eyes of New Zealand white rabbits; 8 eyes received sham surgeries. Rabbits were monitored clinically and then sacrificed 6 or 12 months after surgery for histopathological examination of ocular tissues. RESULTS: Biomicroscopic examination revealed mild ocular changes in all surgical eyes during the first 3 months postoperatively. After that, there was a high incidence of posterior synechias, flare, and posterior capsule opacification (PCO) in eyes with PMMA IOLs. Posterior synechias and flare scores remained mild to moderate throughout the study, whereas PCO severity increased over time. Similar findings were observed in sham eyes. In addition, several eyes with PMMA IOLs developed IOL dislocation, hyphema, iris bombe, and a fibrous membrane covering the IOL. No discernible differences in biomicroscopic scores were observed in eyes at 6 or 12 months. Intraocular pressures and morphology of the corneal endothelium were normal in both groups. Results from histopathological analysis of the ocular tissues were consistent with observations from the biomicroscopic examinations. CONCLUSION: The results suggest that IOL implantation studies in the pseudophakic rabbit eye should be conducted for 3 or fewer months. Regulatory guidelines requiring longer ocular implantation studies should be revised to reflect the inherently rapid and extensive ocular response in the rabbit model.

Functional improvement after phacoemulsification cataract surgery.

PURPOSE: To evaluate subjective functional visual improvement after phacoemulsification and intraocular lens (IOL) implantation and identify patient characteristics and treatment features associated with no functional improvement. SETTING: Academic referral practice, Cullen Eye Institute, Department of Ophthalmology, Baylor College of Medicine, Houston, Texas, USA. METHODS: A retrospective review was performed of the surgical results in 106 consecutive eyes of 102 patients who completed the American Society of Cataract and Refractive Surgery (ASCRS) Cataract Data Collection Form preoperatively and 1 month postoperatively. One surgeon performed all the surgery. The relationship of patient characteristics and treatment features and reported visual function was analyzed using an analysis of variance and the Wilcoxon rank sum and Fisher exact tests. RESULTS: One month postoperatively, all patients demonstrated improved visual acuity. However, 15 patients (14%) reported unimproved or decreased visual function. No statistically significant intergroup difference (P > .05) was detected in mean preoperative, postoperative, and fellow eye best spectacle-corrected visual acuities or refractive errors; reported severity of preoperative symptoms or satisfaction with vision; reported preoperative daily activity functioning or prevalence of hypertension and diabetes; type of anesthesia, lens material, or wound closure used; intraoperative or postoperative complication rates. However, patients reporting unimproved vision tended to be older and less satisfied with their quality of life and medical care than those reporting improved vision (P = .02, .03, .01, respectively). CONCLUSIONS: Self-reported visual function generally improved after phacoemulsification and IOL implantation; however, some older patients less satisfied with their quality of life and medical care reported no functional improvement despite improved visual acuity. These patients might benefit from an extended preoperative discussion of postoperative expectations.

Corneal topography classification in myopic eyes based on axial, instantaneous, refractive, and profile difference maps.

PURPOSE: To refine and develop systems for classifying the topography of myopic corneas using axial, instantaneous, refractive, and profile difference maps. SETTING: Baylor College of Medicine, Cullen Eye Institute Houston, Texas, USA. METHODS: Using the EyeSys Corneal Analysis System, computerized videokeratographs of 153 corneas of 78 myopic patients were retrospectively analyzed. Patterns were defined with respect to the mid-dioptric green color. Relationships among pattern types, refractive power, corneal power, corneal uniformity index (CU index), and predicted corneal visual acuity (PC acuity) were calculated. RESULTS: Six types of patterns for axial, instantaneous, and refractive maps and 3 types of patterns for the profile difference map were defined. For a given cornea, there was a weak correlation among the patterns in the axial, instantaneous, and profile difference maps. The circular with central irregularity pattern in auto-scale refractive maps and the irregular pattern in profile difference maps and axial maps were correlated with lower CU index and PC acuity values. Clinical classification of instantaneous maps did not contribute substantially to the information provided by axial maps. CONCLUSION: Patterns of computerized videokeratographs varied according to the type of topographic map. The classification systems used provide a baseline for analyzing the response of the cornea to various interventions.

Preoperative screening of contact lens wearers before refractive surgery.

PURPOSE: To evaluate corneal stability, measured by computerized videokeratography (CVK) after discontinuation of contact lens wear in preoperative refractive surgery candidates. SETTING: Baylor College of Medicine, Cullen Eye Institute, Houston, Texas, USA. METHODS: Topographic differences were analyzed in 136 noncontact lens wearers (NCLW) and 76 contact lens wearers (CLW) (18 rigid gas-permeable contact lenses [RGPCL], 58 soft contact lenses [SCL]) using EyeSys CVK after discontinuation of SCL wear for 2 weeks and RGPCL wear for 5 weeks. RESULTS: There were no differences in CVK patterns between the NCLW and the CLW groups. There were no statistically significant differences between the 2 groups in topographic symmetry, asphericity, corneal uniformity index, predicted corneal acuity, and irregular astigmatism. The dioptric range for the axial and the profile difference maps in the CLW group was slightly lower than in the NCLW group. CONCLUSIONS: For patients whose manifest refraction and CVK maps were within 0.5 diopters of earlier values, discontinuation of SCL wear for 2 weeks and RGPCL wear for 5 weeks was adequate for the cornea to return to its baseline topographic state.

Corneal topographic changes induced by excision of perilimbal lesions.

BACKGROUND AND OBJECTIVES: To evaluate corneal topographic changes induced by excision of two pterygia and a perilimbal dermoid. MATERIAL AND METHODS: Using the EyeSys Corneal Analysis System, we retrospectively analyzed the changes in astigmatism, mean central corneal power, and other topographic parameters of three corneas before and after surgical removal of two pterygia and a perilimbal dermoid. RESULTS: Marked corneal steepening occurred along the preoperative flat meridian after the excision of the pterygia and dermoid cyst. For each patient, surgery increased the mean central corneal curvature and decreased total astigmatism. CONCLUSION: Surgical excision can ameliorate abnormal corneal topographic changes produced by limbal lesions.

Pediatric cataracts.

There have been major changes over the past 5 to 10 years in our understanding of both the chemical basis for and the surgical treatment of cataract in infants and children. Important questions that remain to be answered include the appropriate power and design selection criteria for intraocular lens implantation, as well as management of the posterior capsule and long-term refractive sequelae. In the past 10 years, there have been radical changes in the management of visually significant cataract in the infant and child. Whereas lens removal, subtotal posterior capsulectomy, vitrectomy, and aphakia were once the standard of care, many physicians now feel that small incisions, phacoemulsification technology, and intraocular lenses (IOLs) are best for these patients. Work is continuing to accumulate a significant body of evidence to evaluate results of these changes in technique and to develop optimal IOL designs and selection criteria for these specialized cataract patients.