Scleral Lens Fitting Using Wide-Field OCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Keratoconus, Irregular; Contour of Cornea. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Trial of OCT-based Scleral Lens Fitting With Wide-Field OCT
Overview
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.
Primary outcome measures
- Apical Clearance [Time frame: 5 years]
- Limbal Clearance [Time frame: 5 years]
- Conjunctival Compression [Time frame: 5 years]
- Lens Edge Lift [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Oregon Health & Science University, Casey Eye Institute — Portland
Identifiers
NCT: NCT04570020 · 6612-SCLERAL LENS · R01EY028755