Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926975
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
MKWalker, University of Houston

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.

Condition or disease Intervention/treatment Phase
Ocular Hypertension Device: Scleral Lens Other: No lens Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
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
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Maria Walker, OD, MS 7137436421 mkwalker@central.uh.edu

Locations
Layout table for location information
United States, Texas
University Eye Institute Recruiting
Houston, Texas, United States, 77204
Contact: Maria Walker, OD, MS    713-743-2015    mkwalker@central.uh.edu   
Sponsors and Collaborators
University of Houston

Layout table for additonal information
Responsible Party: MKWalker, Lecturer, University of Houston
ClinicalTrials.gov Identifier: NCT03926975     History of Changes
Other Study ID Numbers: STUDY00000747
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Ocular Hypertension
Eye Diseases