A focused air-pulse system for optical-coherence-tomography-based measurements of tissue elasticity.

Accurate non-invasive assessment of tissue elasticity in vivo is required for early diagnostics of many tissue abnormalities. We have developed a focused air-pulse system that produces a low-pressure and short-duration air stream, which can be used to excite transient surface waves (SWs) in soft tissues. System characteristics were studied using a high-resolution analog pressure transducer to describe the excitation pressure. Results indicate that the excitation pressure provided by the air-pulse system can be easily controlled by the air source pressure, the angle of delivery, and the distance between the tissue surface and the port of the air-pulse system. Furthermore, we integrated this focused air-pulse system with phase-sensitive optical coherence tomography (PhS-OCT) to make non-contact measurements of tissue elasticity. The PhS-OCT system is used to assess the group velocity of SW propagation, which can be used to determine Young's modulus. Pilot experiments were performed on gelatin phantoms with different concentrations (10%, 12% and 14% w/w). The results demonstrate the feasibility of using this focused air-pulse system combined with PhS-OCT to estimate tissue elasticity. This easily controlled non-contact technique is potentially useful to study the biomechanical properties of ocular and other tissues in vivo.

Surgically induced astigmatism after implantation of intacs intrastromal corneal ring segments.

PURPOSE: To analyze surgically induced astigmatism (SIA) after implantation of Intacs intrastromal corneal ring segments. SETTING: Multicenter clinical trials in the United States. METHODS: Data from 11 investigational sites involved in the Phase II and III trials of Intacs for the United States Food and Drug Administration were retrospectively analyzed. The distribution of Intacs thicknesses implanted in 449 eyes was 0.25 mm in 148 eyes, 0.30 mm in 151 eyes, and 0.35 mm in 150 eyes. Refractive astigmatism was measured by subjective manifest refraction preoperatively and 1 week and 1, 2, 3, 6, 9, and 12 months postoperatively. The mean simple change in astigmatism and the surgically induced refractive change were determined by vector analysis. RESULTS: Mean induced astigmatism at 12 months was 0.13 diopter (D) +/- 0.52 (SD). Induced astigmatism was more frequently with the rule (44%) than against the rule (26%) or oblique (30%). Maximal mean astigmatism was 0.50 +/- 1.09 D and occurred at 7 days. Mean induced astigmatism increased with segment thickness (0.01 D, 0.17 D, and 0.21 D for the 0.25 mm, 0.30 mm, and 0.35 mm segments, respectively). Mean surgically induced refractive change in cylinder power in all eyes at 12 months by vector analysis was 0.17 D x 92. CONCLUSION: Mean SIA was not clinically meaningful 12 months after Intacs implantation.

Clinical characteristics of lamellar channel deposits after implantation of intacs.

PURPOSE: To report the frequency, location, and severity of biomicroscopically evident intrastromal deposits that may accumulate in the lamellar channel after implantation of Intacs corneal ring segments. SETTING: United States Food and Drug Administration multicenter clinical trial conducted at 10 sites. METHODS: Two-year follow-up data from a phase III clinical trial (N = 359) were reviewed. Examiners at 10 study sites described the location and severity (density) of deposits, grading severity on a standardized scale from absent (0) to severe (4). At 24 months, the incidence of deposits was 74% overall and 61%, 73%, and 89% with the 0.25, 0.30, and 0.35 mm Intacs, respectively (P <.001). The incidence increased sharply at first and more slowly after 6 months. RESULTS: At 12 months, deposits were located along the inner curvature of the segments in 47% of patients, along the outer curvature in 5%, along both inner and outer curvatures in 38%, and anterior to the segments in 10%. The severity of the deposits increased with segment thickness (P <.001 at 6, 12, and 24 months). CONCLUSIONS: Lamellar channel deposits occurred frequently after Intacs implantation. The incidence and density of deposits increased with segment thickness and duration of implantation. The presence of this material did not result in alteration of the optical performance of Intacs or anatomical or physiological corneal deterioration.

Diurnal stability of refraction after implantation with intracorneal ring segments.

PURPOSE: To investigate diurnal changes in visual acuity and refraction in myopic eyes implanted with intracorneal ring segments (ICRS). SETTING: University of California San Diego Shiley Eye Center, La Jolla, California, and Emory University Vision Correction Center, Atlanta, Georgia, USA. METHODS: This prospective study involved 2 groups of patients who had ICRS (Intacs) implantation and a follow-up of at least 6 months. The first group included 102 eyes of 51 bilaterally treated patients; the second group, 32 eyes of 16 unilaterally treated patients. Examinations including visual acuity, manifest refraction, and videokeratography were done in the morning and evening at least 9 hours apart on a single day. Refractive changes were analyzed by power vectors; multivariate statistics were used to determine the significance of change in any component of the spectacle prescription. RESULTS: In the bilateral treatment group, 97 eyes (95%) were within 1 line of spectacle-corrected visual acuity from morning to evening. The mean change in manifest refraction was -0.14 +0.08 x 4 and in spherical equivalent, -0.10 diopters (D) (sigma = 0.3; range -0.750 to +0.875 D). Ninety-six eyes (94%) had a change in refraction within 0.50 D of spherical equivalent. There was no significant change in corneal power (P =.20). In the unilateral treatment group, there was no significant difference between treated and untreated eyes in changes in spectacle-corrected visual acuity, manifest refraction, or corneal power and toricity (P.05). CONCLUSION: No clinically significant diurnal variation in visual acuity or manifest refraction was observed after ICRS implantation or in untreated paired eyes. Moreover, the data suggest less diurnal change in visual acuity and refraction after ICRS implantation.

A comparison of visual acuity, predictability, and visual function outcomes after intracorneal ring segments and laser in situ keratomileusis.

PURPOSE: To compare correction of low myopia by intrastromal corneal ring segments (ICRS) and by laser in situ keratomileusis (LASIK) with respect to early visual recovery and refractive outcomes. METHODS: Eighty-two eyes implanted with ICRS in a phase III study for US Food and Drug Administration review were matched with 133 eyes treated with LASIK by criteria of age (> 18 years, < 65 years), preoperative myopia (-1.00 to -3.50 diopters [D]), astigmatism (< or = 1.00 D), single treatment, and attempted full correction. Examinations were performed preoperatively and postoperatively at days 1 and 7 and months 1 and 3. Visual acuity and manifest refraction data were collected retrospectively. Visual function scores were assigned, and summarized results were compared. RESULTS: Uncorrected visual acuity was 20/20 or better at day 1 in 24% of eyes (20/82) after ICRS and in 55% of eyes (73/133) after LASIK, and at month 3 in 75% of eyes (58/77) after ICRS and in 67% of eyes (84/126) after LASIK. Spherical equivalent refraction at month 3 was within +/- 1.00 D of intended correction in 99% of eyes (76/77) after ICRS and in 96% of eyes (121/126) after LASIK. Excellent visual function scores were noted at month 3 in 90% of eyes (69/77) after ICRS and in 78% of eyes (98/126) after LASIK. CONCLUSION: Patients treated with LASIK showed better uncorrected visual acuity immediately following surgery; however, beyond 1 month, patients treated with ICRS achieved better uncorrected visual acuity that continued to improve with time. Visual function scores indicate that ICRS eyes see at higher levels of uncorrected visual acuity than LASIK eyes do with the same refractive error. The ICRS and LASIK were comparable in the correction of mild myopia.

Twenty-four-hour pattern of intraocular pressure in the aging population.

PURPOSE: To characterize the 24-hour pattern of intraocular pressure (IOP) in a sample of the aging human population. METHODS: Twenty-one healthy volunteers 50 to 69 years of age were housed in a sleep laboratory for 24 hours. Experimental conditions were strictly controlled with a 16-hour light period and an 8-hour dark period. Sleep was encouraged in the dark period. Intraocular pressure was measured using a pneumatonometer every 2 hours (total of 12 times). Measurements were taken in both the sitting position and the supine position during the light/wake period but only in the supine position during the dark period. RESULTS: When the sitting IOP data from the light/wake period and the supine IOP data from the dark period were considered, elevation and reduction of IOP occurred around the scheduled lights-off and lights-on transitions, respectively. Mean IOP in the dark period was significantly higher than mean IOP in the light/wake period. The trough appeared at the end of the light/wake period, and the peak appeared at the beginning of the dark period. The magnitude of trough-peak difference was 8.6+/-0.8 mm Hg (mean +/- SEM). Cosine fits of 24-hour IOP data showed a significant 24-hour rhythm. When IOP data from just the supine position were analyzed, the trough-peak IOP difference was 3.4+/-0.7 mm Hg, with similar clock times for the trough and the peak. Cosine fits of supine IOP data showed no statistically significant 24 hour rhythm. CONCLUSIONS: Nocturnal elevation of IOP occurred in this sample of the aging population. The trough of IOP appeared at the end of the light/wake period, and the peak appeared at the beginning of the dark period. The main factor in the nocturnal IOP elevation appeared to be the shift from daytime upright posture to supine posture at night.

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.

Elevation of human intraocular pressure at night under moderate illumination.

PURPOSE: An endogenous elevation of intraocular pressure (IOP) occurs at night in healthy young adults. The authors studied whether or not this IOP elevation can be detected under moderate illumination. METHODS: Twenty-five healthy volunteers, ages 18 to 25 years, were housed overnight in a sleep laboratory under a strictly controlled light-dark environment. Intraocular pressure was measured in the supine position every 2 hours, using a pneumatonometer. An 8-hour sleep period was assigned to each volunteer according to individual's accustomed sleep cycle. In the early part of this assigned period, sleep was encouraged with room lights off. Researchers performed IOP measurements at two time points with the aid of night vision goggles. In the middle to the late part of the assigned period, lights were turned on twice for a 1-hour interval. The light intensity was the same as before the bedtime. At the ending of each light period, IOP was measured under illumination. RESULTS: Average IOP was significantly higher in the assigned sleep period versus outside the period. The trough of mean IOP occurred just before the bedtime, and then IOP gradually increased and peaked at the end of the 8-hour assigned sleep period. The difference between the trough and peak IOP was 3.5 +/- 0.7 mm Hg (mean +/- SEM, n = 25). Within the assigned sleep period, the average IOP determined under illumination was significantly higher than the average IOP preceding the illumination. CONCLUSIONS: Elevation of IOP occurred during the assigned sleep period with two 1-hour light exposures of moderate intensity. Environmental light at night had no significant effect on the nocturnal IOP elevation in healthy young adults.

Nocturnal elevation of intraocular pressure in young adults.

PURPOSE: To distinguish 24-hour (circadian) and postural effects on intraocular pressure (IOP) in healthy young adults. METHODS: Thirty-three volunteers were housed in a sleep laboratory for 1 day under a strictly controlled 16-hour light and 8-hour dark environment. Sleep was encouraged in the dark period. Intraocular pressure was measured in each eye every 2 hours using a pneumatonometer. Researchers used night-vision goggles to perform IOP measurements in the dark, while the subject's light exposure was minimized. In the first group of 12 subjects, measurements were taken with subjects in the sitting position during the light-wake period and supine during the dark period. In the second group of 21 subjects, all IOP measurements were taken with the subjects supine. RESULTS: Average IOP was significantly higher in the dark period than in the light-wake period in both groups. The lowest IOP occurred in the last light-wake measurement, and the peak IOP occurred in the last dark measurement. The trough-peak difference in IOP was 8.2+/-1.4 mm Hg (mean +/- SEM) in the first group. Intraocular pressure changed sharply at the transitions between light and dark. In the second group, the trough-peak IOP difference was 3.8+/-0.9 mm Hg. Intraocular pressure changed gradually throughout the 24-hour period. In comparison with the sitting IOP in the first group, the supine IOP in the second group was significantly higher during the light-wake period. CONCLUSIONS: Circadian rhythms of IOP were shown in young adults, with the peaks occurring in the late dark period. A nocturnal IOP elevation can appear independent of body position change, but change of posture from upright to recumbent may contribute to the relative nocturnal IOP elevation.