NCT04570020|Recruiting
Scleral Lens Fitting Using Wide-Field OCT
Clinical Trial of OCT-based Scleral Lens Fitting With Wide-Field OCT
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Clinical Trial of OCT-based Scleral Lens Fitting With Wide-Field OCT
Sponsor study identifier
Secondary identifiers
NIH
observational
258
1 country
1
Study Start
September 23, 2020
Actual (reported)Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 23, 2020
Actual (reported)September 24, 2020
Actual (reported)September 30, 2020
Actual (reported)December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Apical Clearance
Apical clearance of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable," "too high," or "too low."
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."
5 years
Conjunctival Compression
Conjunctival compression of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable" or "excessive."
5 years
Lens Edge Lift
Lens edge lift for each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable" or "excessive."
5 years
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.
Male and female subjects meeting the eye criteria listed above.
Oregon Health & Science University, Casey Eye Institute
Portland, Oregon, 97239, United States
David Huang, MD, PhD
Oregon Health and Science University
First Submitted
September 24, 2020
First Posted
September 30, 2020
Study Start
September 23, 2020
Actual (reported)Primary Completion
December 2027
EstimatedValidation of Innovative Scheimpflug Topography Derived RGP Contact Lens Designs In Optometry Network
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 9, 2025
Record last verified: 2025-09
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Source: ClinicalTrials.gov.
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