Scleral Lens Fitting Using Wide-Field OCT

Keratoconus Clinical Trial

Official title:

Clinical Trial of OCT-based Scleral Lens Fitting With Wide-Field OCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04570020
• Other study ID #: 6612-SCLERAL LENS
• Secondary ID: R01EY028755
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Irregular; Contour of Cornea
• Keratoconus

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