The Effect of a Scleral Lens on the Anterior Chamber Depth and Minimum Rim Width
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|ClinicalTrials.gov Identifier: NCT03926975|
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : January 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ocular Hypertension||Device: Scleral Lens Other: No lens||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Subjects are all non-scleral lens wearers. One eye (test) will be selected to wear a scleral lens, and the contralateral eye (control) will not wear any lens.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effect of a Scleral Lens on the Anterior Chamber Depth and Minimum Rim Width|
|Actual Study Start Date :||June 1, 2018|
|Actual Primary Completion Date :||June 15, 2019|
|Actual Study Completion Date :||August 30, 2019|
Experimental: Experimental: Scleral Lens
One eye will be randomly selected to wear a scleral lens for a 6-hour testing period.
Device: Scleral Lens
The contact lens will be worn on one eye.
Active Comparator: Control: no lens
The contralateral eye will not wear a lens.
Other: No lens
No lens worn on the contralateral control eye
- Change in minimum rim width from baseline to 6-hours SL wear [ Time Frame: 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.
- Intraocular pressure (IOP) [ Time Frame: at baseline, after 2-hours lens wear, and after 6-hours lens wear ]IOP will be measured using the Diaton and iCare tonometers
- Anterior Chamber Depth (ACD) [ Time Frame: at baseline, after 2-hours lens wear, and after 6-hours lens wear ]ACD will be measured with the Lenstar A-scan
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926975
|United States, Texas|
|University Eye Institute|
|Houston, Texas, United States, 77204|