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

NCT03926975 | Completed FDA Device

• 1 other identifier: STUDY00000747
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  at baseline, after 2-hours lens wear, and after 6-hours lens wear

Secondary Outcomes (2)

• 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

Study Arms (2)

Experimental: Scleral Lens

EXPERIMENTAL

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

Device: Scleral Lens

Control: no lens

ACTIVE COMPARATOR

The contralateral eye will not wear a lens.

Other: No lens

Interventions

Scleral Lens DEVICE

The contact lens will be worn on one eye.

Experimental: Scleral Lens

No lens OTHER

No lens worn on the contralateral control eye

Control: no lens

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• young, normal individuals

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Houston: lead

Study Sites (1)

University Eye Institute

Houston, Texas, 77204, United States

Location

Related Publications (1)

• 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.

  PMID: 32932395 DERIVED

MeSH Terms

Conditions

Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Maria Walker

  University of Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 25, 2019
• Study Start: June 1, 2018
• Primary Completion: June 15, 2019
• Study Completion: August 30, 2019
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

US (1)