Health TrialsbyHealthPanel

Scleral Lens Fitting Using Wide-Field OCT

ConditionsKeratoconusIrregular; Contour of Cornea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOregon Health and Science University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eyes requiring fit for scleral lenses for KCN, post-PK, post-RK, post-LASIK ectasia, or various anterior surface disorders

Disqualifiers

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

Trial population

Male and female subjects meeting the eye criteria listed above.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

258 Participants
are grouped into 2 trial groups
Group A: Clinically-Selected Scleral Lens
Group B: OCT-Selected Scleral Lens

Trial outcomes

Primary outcomes

1

Apical Clearance

Apical clearance of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable," "too high," or "too low."

Time frame
5 years
2

Limbal Clearance

Limbal clearance of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable," "too much," or "too little."

Time frame
5 years
3

Conjunctival Compression

Conjunctival compression of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable" or "excessive."

Time frame
5 years
4

Lens Edge Lift

Lens edge lift for each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable" or "excessive."

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

National Eye Institute (NEI)

Collaborator

Source ClinicalTrials.gov
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