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Scleral Lens Fitting Using Wide-Field OCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04570020
Recruitment Status : Active, not recruiting
First Posted : September 30, 2020
Last Update Posted : September 30, 2020
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University

Study Description
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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.

Condition or disease
Keratoconus Irregular; Contour of Cornea

Study Design
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Study Type : Observational
Estimated Enrollment : 258 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Trial of OCT-based Scleral Lens Fitting With Wide-Field OCT
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Groups and Cohorts
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Group/Cohort
Clinically-Selected Scleral Lens
The clinically-selected lens is based on slit lamp assessment. This lens will be compared against an OCT-selected lens.
OCT-Selected Scleral Lens
The OCT-selected lens is based on OCT measurements. This lens will be compared against a clinically-selected lens.


Outcome Measures
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Primary Outcome Measures :
  1. Apical Clearance [ Time Frame: 5 years ]
    Apical clearance of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable," "too high," or "too low."

  2. Limbal Clearance [ Time Frame: 5 years ]
    Limbal clearance of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable," "too much," or "too little."

  3. Conjunctival Compression [ Time Frame: 5 years ]
    Conjunctival compression of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable" or "excessive."

  4. Lens Edge Lift [ Time Frame: 5 years ]
    Lens edge lift for each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable" or "excessive."


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female subjects meeting the eye criteria listed above.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570020


Locations
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United States, Oregon
Oregon Health & Science University, Casey Eye Institute
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Eye Institute (NEI)
Investigators
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Principal Investigator: David Huang, MD, PhD Oregon Health and Science University
More Information
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Responsible Party: David Huang, Peterson Professor of Ophthalmology & Professor of Biomedical Engineering, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT04570020    
Other Study ID Numbers: 6612-SCLERAL LENS
R01EY028755 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Huang, Oregon Health and Science University:
Keratoconus (KCN)
Irregular Cornea
Optical Coherence Tomography (OCT)
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases