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

Primary Purpose

Ocular Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scleral Lens
No lens
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ocular Hypertension

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • young, normal individuals

Exclusion Criteria:

  • 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

Sites / Locations

  • University Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: Scleral Lens

Control: no lens

Arm Description

One eye will be randomly selected to wear a scleral lens for a 6-hour testing period.

The contralateral eye will not wear a lens.

Outcomes

Primary Outcome Measures

Change in minimum rim width from baseline to 6-hours SL wear
The Bruch's membrane opening to the inner limiting lamina (termed the minimum rim width) will be measured at the optic nerve head.

Secondary Outcome Measures

Intraocular pressure (IOP)
IOP will be measured using the Diaton and iCare tonometers
Anterior Chamber Depth (ACD)
ACD will be measured with the Lenstar A-scan

Full Information

First Posted
April 18, 2019
Last Updated
January 28, 2021
Sponsor
University of Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03926975
Brief Title
The Effect of a Scleral Lens on the Anterior Chamber Depth and Minimum Rim Width
Official Title
The Effect of a Scleral Lens on the Anterior Chamber Depth and Minimum Rim Width
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Scleral Lens
Arm Type
Experimental
Arm Description
One eye will be randomly selected to wear a scleral lens for a 6-hour testing period.
Arm Title
Control: no lens
Arm Type
Active Comparator
Arm Description
The contralateral eye will not wear a lens.
Intervention Type
Device
Intervention Name(s)
Scleral Lens
Intervention Description
The contact lens will be worn on one eye.
Intervention Type
Other
Intervention Name(s)
No lens
Intervention Description
No lens worn on the contralateral control eye
Primary Outcome Measure Information:
Title
Change in minimum rim width from baseline to 6-hours SL wear
Description
The Bruch's membrane opening to the inner limiting lamina (termed the minimum rim width) will be measured at the optic nerve head.
Time Frame
at baseline, after 2-hours lens wear, and after 6-hours lens wear
Secondary Outcome Measure Information:
Title
Intraocular pressure (IOP)
Description
IOP will be measured using the Diaton and iCare tonometers
Time Frame
at baseline, after 2-hours lens wear, and after 6-hours lens wear
Title
Anterior Chamber Depth (ACD)
Description
ACD will be measured with the Lenstar A-scan
Time Frame
at baseline, after 2-hours lens wear, and after 6-hours lens wear

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: young, normal individuals Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Walker
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Eye Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32932395
Citation
Walker MK, Pardon LP, Redfern R, Patel N. IOP and Optic Nerve Head Morphology during Scleral Lens Wear. Optom Vis Sci. 2020 Sep;97(9):661-668. doi: 10.1097/OPX.0000000000001567.
Results Reference
derived

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

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