What this study is
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.
Study details
- Official title
- Clinical Trial of OCT-based Scleral Lens Fitting With Wide-Field OCT
- Sponsor
- Oregon Health and Science University
- Conditions
- Keratoconus · Irregular; Contour of Cornea
- Enrolling
- 258 people
- Starts
- 2020-09-23
- Est. completion
- 2028-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Eyes requiring fit for scleral lenses for KCN, post-PK, post-RK, post-LASIK ectasia, or various anterior surface disorders
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openOregon Health & Science University, Casey Eye Institute
Portland, Oregon, United States
- Humberto Martinez, COT · Contact503-494-7712martinhu@ohsu.edu
- Denzil Romfh, OD · Contact503-494-4351romfhd@ohsu.edu
- Winston Chamberlain, MD, PhD · Sub-investigator
- Afshan Nanji, MD · Sub-investigator
- Derek Louie, OD · Sub-investigator
- Yan Li, PhD · Sub-investigator
- Richard Stutzman, MD · Sub-investigator
Recruiting
Study team
Sponsor
Oregon Health and Science University
Study ID 6612-SCLERAL LENS
Principal investigator
David Huang, MD, PhD
Oregon Health and Science University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.