Ignite Creation Date:
2024-05-06 @ 1:04 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03926975
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2019-04-18
Brief Title:
The Effect of a Scleral Lens on the Anterior Chamber Depth and Minimum Rim Width
Sponsor:
University of Houston
Organization:
University of Houston
Study Overview
Official Title:
The Effect of a Scleral Lens on the Anterior Chamber Depth and Minimum Rim Width
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 Bruchs 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
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 Bruchs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None