Scleral Lens Fitting Using Wide-Field OCT

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04570020

Enrollment

258

Registered

2020-09-30

Start date

2020-09-23

Completion date

2028-12-31

Last updated

2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irregular; Contour of Cornea, Keratoconus

Keywords

Keratoconus (KCN), Irregular Cornea, Optical Coherence Tomography (OCT)

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactHumberto Martinez, COT

martinhu@ohsu.edu503-494-7712

Backup ContactDenzil Romfh, OD

romfhd@ohsu.edu503-494-4351

Outcome results