The Berkeley Contact Lens Extended Wear Study. Part I : Study design and conduct.

OBJECTIVE: The primary aim of the Berkeley Contact Lens Extended Wear Study (CLEWS) was to test the hypotheses that extended wear of rigid gas-permeable (RGP) contact lenses with greater oxygen permeability (Dk) reduces the incidence of contact lens-associated keratopathy (CLAK) and increases the survival rate in RGP extended wear (EW). In this article we describe the clinical trial design in detail, present the results of subject recruitment and retention, and provide the baseline demographic and ocular characteristics of the CLEWS subjects, whose data will be analyzed to address the study aims in a companion article. DESIGN: A randomized, concurrently controlled clinical trial. INTERVENTION: Subjects were fitted with day wear (DW) high-Dk RGP lenses and then adapted to EW. Subjects who adapted to EW were then randomly assigned to either high- or medium-Dk RGP lenses for 12 months of 6-nights/week EW. MAIN OUTCOME MEASURES: Slit-lamp assessment and grading of 17 possible keratopathies, measurement of refractive error and corneal curvature, and symptoms. Follow-up data were collected every 3 months. RESULTS: From 545 subjects entering the DW adaptation phase, 201 adapted to EW and were randomly assigned to medium- or high-Dk lenses for 12 months of EW. The baseline characteristics of the two study groups were similar and did not differ from the 344 DW subjects who failed to adapt to EW. The distributions of oxygen transmissibility for the two study groups were disjoint, indicating that each group received distinctly different levels of hypoxia. CONCLUSIONS: We show that CLEWS was appropriately designed to address the study hypotheses, was conducted with regard for the safety of the subjects, and adhered to rigorous protocols designed to control for bias and ensure the integrity of study data. We establish the internal validity of between-group statistical comparisons and characterize our study population to permit informed evaluation of the applicability of our results to the contact lens-wearing population in general.

The Berkeley Contact Lens Extended Wear Study. Part II : Clinical results.

OBJECTIVE: To describe the principal clinical outcomes associated with 12 months use of rigid gas-permeable (RGP) extended wear contact lenses and address two primary study questions: (1) does extended wear (EW) of high oxygen transmissibility (Dk/t) RGP lenses reduce the incidence of ocular complications, and (2) does the wearing of high-Dk/t lenses reduce the rate of failure to maintain 6-night RGPEW over 12 months? DESIGN: A randomized, concurrently controlled clinical trial. INTERVENTION: Subjects who adapted to EW with high Dk (oxygen permeability) RGP lenses were randomized to either high Dk or medium-Dk RGP lenses for 12 months of 6-night EW. MAIN OUTCOME MEASURES: Contact lens-associated keratopathies (CLAK), changes in refractive error and corneal curvature, and survival in EW. RESULTS: Two hundred one subjects were randomized to medium or high-Dk lenses for 12 months of EW. Sixty-two percent of the subjects in each group completed 12 months of EW; however, the probability of failure was significantly greater for the medium-Dk group. Although the risk of complications was similar for the two groups, the number of CLAK events that led to termination were 16 versus 5 for the medium-Dk and high-Dk groups, respectively. This suggests that the type of adverse response or the inability to reverse an adverse event was different for the group being exposed to the lower oxygen dose. CONCLUSIONS: The level of oxygen available to the cornea has a significant impact on maintaining successful RGP extended contact lens wear, but not on the initial onset of CLAK. The number of clinical events leading to termination was substantially higher for the medium Dk group, which suggests that corneal hypoxia is an important factor in the development of CLAK. Although overnight contact lens wear should be recommended with caution and carefully monitored for early detection of ocular complications, it appears that high-Dk RGP lenses can be a safe and effective treatment for correction of refractive error for most individuals who can adapt to EW.

Predicting RGP daily wear success.

PURPOSE: While most clinicians agree that fitting of rigid gas permeable (RGP) lenses is the preferred treatment strategy for some types of patients, many patients have difficulty adapting to full-time daily wear of these lenses. The Contact Lens Extended Wear Study (CLEWS) is a randomized, controlled clinical trial in which subjects are first adapted to full-time RGP daily wear prior to randomization to either high or medium oxygen transmissibility (Dk/L) RGP lenses for 12 months of extended wear. The CLEWS pre-randomization data provide an opportunity to examine the reasons some patients fail to adapt to RGP daily wear and to determine whether a patient's demographic, historical, and ocular characteristics can be used to predict RGP daily wear success. METHODS: From 1,809 individuals who expressed interest in RGP lenses, 411 subjects passed the CLEWS screening criteria and were fit with high Dk lenses (mean Dk = 92 x 10(-11) [cm2/sec][mL 02/mL x mmHg]). The fitting strategy included minimum apical alignment, lid attachment, centration, and average lens diameters of 9.2 mm. Success was defined as a minimum of 14 hours per day without adverse ocular responses that would contraindicate either full-day daily wear or extended wear. RESULTS: Of the 411 subjects, 286 (69.6%) were successful with RGP extended wear. Among the 125 failures, 50 were based on clinician findings (e.g., cornea, vision, compliance), while 75 subjects chose to discontinue wear because of unacceptable comfort or poor vision. Multivariate linear logistic regression modeling shows that younger patients with greater corneal curvature (K) and less predicted residual astigmatism have a higher probability of RGP daily wear success. CONCLUSIONS: Our study showed that RGP lenses can be fit with a relatively high rate of success and that many of those patients who elect to discontinue RGP daily wear report unacceptable comfort as the primary reason. We propose a Bayesian statistical method that will assist clinicians in selecting those candidates for RGP daily wear who are most likely to adapt successfully.

Sequential staining: the effects of sodium fluorescein, osmolarity, and pH on human corneal epithelium.

BACKGROUND: Previous reports have suggested that sequential applications of sodium fluorescein (NaF) to the ocular surface cause loss of epithelial cells. In those experiments the solutions were free of preservatives, but delivered a hypertonic and alkaline load. It is possible that either the hyperosmolarity, NaF, and/or alkalinity may have contributed to the epithelial cell loss. Our study explored the possible impact of these three factors on epithelial integrity. METHODS: We used a paradigm in which we designed four test solutions to isolate the cytotoxic effects of the three factors. Fifteen subjects were exposed to one of the solutions on separate visits. One solution was instilled in both eyes, every 3 min, for a total of seven applications, and a slitlamp examination was performed. Staining was graded on a scale of 0 to 3 for each of five corneal sectors. RESULTS: Application of solution 1 (NaF, hyperosmotic, and alkaline) resulted in staining for all subjects. For the other three solutions (without NaF), insignificant staining occurred. CONCLUSIONS: The epithelium tolerates changes in pH and osmolarity between 7.2 to 7.8 and 290 to 350, respectively. However, NaF when applied in multiple doses may be cytotoxic.

Blood pressure measurement by eye care practitioners.

We surveyed a random sample of 250 optometrists (OD) and 250 ophthalmologists (MD) in November 1991 to determine if they were involved in blood pressure measurement. A 50.4 percent and 34.8 percent response rate was obtained from ODs and MDs, respectively. Of those responding, 85 percent of the optometrists and 87 percent of the ophthalmologists reported that they did routinely question their patients about blood pressure, while 65.9 percent of the optometrists and 94.2 percent of the ophthalmologists reported owning blood pressure measurement equipment. Of those owning blood-pressure measuring equipment, approximately 20 percent of both professions reported measuring blood pressure on patients with a defined set of historical or observed risk factors. More optometrists should own blood pressure measurement equipment and measure blood pressure on a routine basis. The detection, referral, and co-management of hypertension by optometrists is important in providing primary health care.

Microwave irradiation and soft contact lens parameters.

We evaluated the effect of repeated microwave irradiation on soft contact lens parameters to determine if microwave disinfection affects soft lens polymers or parameters. Ten factory-sealed lenses from each of the four FDA categories were placed in Ciba AOsept cases which were filled with 13 ml of sterile unpreserved saline. The cases were placed in a 10-cm diameter circle on the rotating plate of a standard 2450 MHz 650 W microwave oven and exposed to repeated 5-min cycles of microwave irradiation. The lens parameters, including back vertex power, back optic zone radius, diameter, thickness and water content, were measured over a period of 200 cycles to simulate over 6 months of daily disinfection. The postirradiation measurements were compared to baseline measurements taken before microwave exposure. We found statistically significant changes in many lens parameters, but all were small and few were clinically significant. These findings indicate that microwave disinfection does not have a clinically significant effect on the parameters of most unworn soft contact lenses. Further studies are needed to determine the long-term effects of microwave disinfection on worn soft contact lenses.

Does the presbyopic visual system adapt to contact lenses?

We studied whether task performance improves during the initial wearing period of selected presbyopic contact lens corrections. In three previous studies significant decreases in performance on three selected tasks were measured before and after initial wearing periods to monovision contact lenses (N = 18, 8 weeks of wear), concentric bifocal lenses (N = 32, 8 weeks), and diffractive and monovision lenses (N = 20, 3 weeks). In each study, the control condition was distance contact lenses with reading spectacles. The decreases in performance speed ranged from 2 to 15% compared to control. In this study, we retrospectively analyze the data to determine whether the task performance decreases relative to control were significantly different after the initial wearing period than at the time of dispensing--i.e., did measures of task performance show an adaptation to the presbyopic contact lens correction? Performance adaptation on each task and for each study was analyzed statistically using the Wilcoxon matched pair signed rank test of each subject's mean performance differences (test vs. control condition) at dispensing compared to the performance at the end of the wearing period. There was no improvement in task performance with monovision or diffractive bifocal lenses. However, we found significant improvements in task performance with concentric bifocal lenses (p < 0.05). Measures of visual acuity and stereoacuity did not improve with these lenses during the studied wearing period. Thus, these basic visual skills did not adapt. The ability of patients to learn how to use reduced visual acuity to perform complex tasks is a possible explanation for the improved task performance with concentric bifocal lenses compared to control.

Vision and task performance with monovision and diffractive bifocal contact lenses.

We measured vision and task performance on 26 presbyopes, ages 46 to 65 years, fitted with diffractive bifocal contact lenses (BFCL) and monovision contact lenses (MVCL). Distance contact lenses combined with reading spectacles (DCL) served as the control condition. Twenty subjects completed the 6-week study. All subjects wore BFCL and MVCL daily for a period of 3 weeks each. Performance times for three near tasks were 6 to 8% longer with BFCL compared with DCL and 2 to 6% longer for MVCL compared with DCL. There were significant reductions in distance visual acuity with BFCL (0.4 to 1.5 Snellen lines) and MVCL (0.5 to 0.8 Snellen lines) compared to DCL. At the conclusion of the study, given a choice between BFCL and MVCL, 2 of the 20 subjects chose to continue wearing BFCL, whereas 18 of the 20 subjects chose MVCL. Our results show greater visual compromise and decreased task performance with BFCL and MVCL compared to DCL and greater patient preference for MVCL.

The pH of over-the-counter hydrogen peroxide in soft lens disinfection systems.

We evaluated the pH of six hydrogen peroxide (H2O2) soft lens disinfection systems which had over-the-counter (OTC) H2O2 substituted for the manufacturer's recommended H2O2. Substitution of four brands of OTC H2O2 into the five two-step disinfection systems resulted in a pH after neutralization which ranged from 6.70 to 7.55 pH units. There was a small but statistically significant difference in the pH after neutralization when OTC H2O2 was substituted for the manufacturer's recommended H2O2. There was a significantly lower pH after neutralization when the same brands of OTC H2O2 were substituted for the manufacturer's recommended H2O2 in a one-step H2O2 disinfection system. The pH after neutralization for the manufacturer's recommended H2O2 was 6.50 pH units. The pH after neutralization for the OTC H2O2 ranged from 3.35 to 4.77 pH units. This range is below the ocular comfort range of 6.6 to 7.8 pH units. These findings, along with other possible differences between OTC H2O2 and the manufacturer's recommended H2O2, indicate that OTC H2O2 should never be substituted for the manufacturer's recommended H2O2 in any H2O2 soft lens disinfection system.