An observational study in Keratoconus and Irregular; Contour of Cornea, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Oregon Health and Science University · Observational
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.
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 258 is above the median of 130 across 97 observational studies indexed under Keratoconus.
Browse Keratoconus studies →Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Male and female subjects meeting the eye criteria listed above.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The clinically-selected lens is based on slit lamp assessment. This lens will be compared against an OCT-selected lens.
The OCT-selected lens is based on OCT measurements. This lens will be compared against a clinically-selected lens.
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
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
Conjunctival Compression
Conjunctival compression of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable" or "excessive."
Time frame: 5 years
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
Started Sep 2020 (actual). Primary completion is estimated for Dec 2027, 87 months after the start.
Of 33 non-industry observational studies under Keratoconus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 204. This study's planned 87 months is above that.
Counting every sponsor, half of 36 studies reached it within 30 months; a quarter within 13 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
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