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临床试验/NCT03926975
NCT03926975已完成不适用

The Effect of a Scleral Lens on the Anterior Chamber Depth and Minimum Rim Width

University of Houston2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Change in minimum rim width from baseline to 6-hours SL wear

研究概览

简要总结

The purpose of this study is to evaluate the use of two instruments to measure changes in two ocular structures: 1) the anterior chamber depth (ACD) - measured using low coherence optical biometry, and 2) minimum rim width of the optic nerve head (MRW) - measured using optical coherence tomography. Changes in these ocular structures indicate fluctuations in intraocular pressure (IOP) and will be measured during scleral contact lens (SGP) wear to determine if SGP wear influences IOP. We hypothesize that a scleral lens increases the intraocular pressure (IOP) during active wear and that the ACD and MRW will also change.

详细描述

Contact lenses are often used to correct vision blur. The most common types of contact lenses include those referred to as 'soft' and 'rigid'. Visual acuity through rigid lenses often surpasses that of soft lenses. Historically, these lenses have been small in diameter, and hence patients also felt discomfort when wearing the lenses. Scleral lenses are relatively new, customized devices that have gained popularity with patients and practitioners in the past 5-10 years, because they are more comfortable and provide more stable vision than the small diameter rigid contact lenses. However, relatively little is known about the physiologic response of the eye to the scleral lens, or the long-term effects of their use, since they are such a new modality.

Maintaining the IOP within the eye is imperative to prevent damage to ocular tissue, which can occur in glaucoma. Given the landing of scleral lens overlying the sclera and ciliary body, which assist in modulating the transport of fluid in the eye, there is a potential for these lenses to impinge on fluid drainage which could lead to increases of IOP during scleral lens wear. The placement of the lens creates an obstacle in evaluating IOP while the lens is actually on the eye (covering the cornea), and since increases in IOP may only occur during lens wear, which is removed when determining clinical IOP measurements, it is difficult to monitor IOP during scleral lens wear with traditional IOP instrumentation (ie. iCare, Goldman, etc).

Optical coherence tomography is a non-invasive imaging technology that has revolutionized how the retina and optic nerve are clinically evaluated. The optic nerve head is typically assessed using radial scans, from which the minimal distance from the Bruch's membrane opening to the inner limiting lamina is quantified as the minimum rim width (MRW). With changes in IOP, the MRW is known to also change in thickness. Many studies are investigating the MRW changes during IOP fluctuations, with studies finding a decrease in MRW during acute IOP increase. In this project, MRW will be used to indirectly assess changes in IOP by measuring the MRW periodically during active scleral lens wear.

In addition, we are incorporating low coherence optical biometry (Lenstar) to evaluate the effect of the scleral lens pressure on the anterior chamber. Using the Lenstar, corneal thickness, anterior chamber depth (ACD), lens thickness and vitreous chamber depth can be quantified. In this project, ACD will be used to indirectly evaluate changes in the pressure within the anterior chamber. The assumption is that the ACD will change based on changes in pressure in the scleral lens tear reservoir.

This study will add to the knowledge of how the scleral lens affects the dynamic pressure system of the eye. Based on the implications for disease with chronic increases and fluctuations in IOP, this is important information to understand with the scleral lens, a relatively new refractive treatment modality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • young, normal individuals

排除标准

  • IOP > 20mm in either eye, and h/o ocular hypertension, glaucoma, or ocular surgery that can affect IOP.
  • h/o scleral lens wear or current scleral lens wear

结局指标

主要结局

Change in minimum rim width from baseline to 6-hours SL wear

时间窗: at baseline, after 2-hours lens wear, and after 6-hours lens wear

The Bruch's membrane opening to the inner limiting lamina (termed the minimum rim width) will be measured at the optic nerve head.

次要结局

  • Intraocular pressure (IOP)(at baseline, after 2-hours lens wear, and after 6-hours lens wear)
  • Anterior Chamber Depth (ACD)(at baseline, after 2-hours lens wear, and after 6-hours lens wear)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

MKWalker

Lecturer

University of Houston

研究点 (2)

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