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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04570020
Other study ID # 6612-SCLERAL LENS
Secondary ID R01EY028755
Status Recruiting
Phase
First received
Last updated
Start date September 23, 2020
Est. completion date December 2026

Study information

Verified date February 2024
Source Oregon Health and Science University
Contact Humberto Martinez, COT
Phone 503-494-7712
Email martinhu@ohsu.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to see if OCT technology can optimize scleral contact lens fittings. Subjects with keratoconus, post-penetrating keratoplasty (PK), post-LASIK ectasia, post-radial keratotomy (RK), or a variety of anterior surface disorders requiring scleral lens fittings will be considered for enrollment. For each study eye, a clinically-selected scleral lens fit will be compared against an OCT-selected lens fit. The quality of each lens fit will be determined by flourescein exam at the slit lamp. Apical clearance, limbal clearance, conjunctival compression, and lens edge lift will be assessed. A lens that satisfies all four criteria will be considered satisfactory.


Recruitment information / eligibility

Status Recruiting
Enrollment 258
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Eyes requiring fit for scleral lenses for KCN, post-PK, post-RK, post-LASIK ectasia, or various anterior surface disorders Exclusion Criteria: - Inability to maintain stable fixation for OCT imaging - Inability to commit to required visits to complete the study - Eyes with concurrent retinal diseases, glaucoma, or other eye conditions that may limit visual outcome

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Oregon Health & Science University, Casey Eye Institute Portland Oregon

Sponsors (2)

Lead Sponsor Collaborator
Oregon Health and Science University National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Apical Clearance Apical clearance of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable," "too high," or "too low." 5 years
Primary Limbal Clearance Limbal clearance of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable," "too much," or "too little." 5 years
Primary Conjunctival Compression Conjunctival compression of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable" or "excessive." 5 years
Primary Lens Edge Lift Lens edge lift for each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable" or "excessive." 5 years
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