Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT04570020
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2020-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Scleral Lens Fitting Using Wide-Field OCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007640', 'term': 'Keratoconus'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 258}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2020-09-24', 'studyFirstSubmitQcDate': '2020-09-24', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apical Clearance', 'timeFrame': '5 years', 'description': 'Apical clearance of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable," "too high," or "too low."'}, {'measure': 'Limbal Clearance', 'timeFrame': '5 years', 'description': 'Limbal clearance of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable," "too much," or "too little."'}, {'measure': 'Conjunctival Compression', 'timeFrame': '5 years', 'description': 'Conjunctival compression of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable" or "excessive."'}, {'measure': 'Lens Edge Lift', 'timeFrame': '5 years', 'description': 'Lens edge lift for each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable" or "excessive."'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Keratoconus (KCN)', 'Irregular Cornea', 'Optical Coherence Tomography (OCT)'], 'conditions': ['Keratoconus', 'Irregular; Contour of Cornea']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female subjects meeting the eye criteria listed above.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eyes requiring fit for scleral lenses for KCN, post-PK, post-RK, post-LASIK ectasia, or various anterior surface disorders\n\nExclusion Criteria:\n\n* Inability to maintain stable fixation for OCT imaging\n* Inability to commit to required visits to complete the study\n* Eyes with concurrent retinal diseases, glaucoma, or other eye conditions that may limit visual outcome'}, 'identificationModule': {'nctId': 'NCT04570020', 'briefTitle': 'Scleral Lens Fitting Using Wide-Field OCT', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Clinical Trial of OCT-based Scleral Lens Fitting With Wide-Field OCT', 'orgStudyIdInfo': {'id': '6612-SCLERAL LENS'}, 'secondaryIdInfos': [{'id': 'R01EY028755', 'link': 'https://reporter.nih.gov/quickSearch/R01EY028755', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clinically-Selected Scleral Lens', 'description': 'The clinically-selected lens is based on slit lamp assessment. This lens will be compared against an OCT-selected lens.'}, {'label': 'OCT-Selected Scleral Lens', 'description': 'The OCT-selected lens is based on OCT measurements. This lens will be compared against a clinically-selected lens.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Humberto Martinez, COT', 'role': 'CONTACT', 'email': 'martinhu@ohsu.edu', 'phone': '503-494-7712'}, {'name': 'Denzil Romfh, OD', 'role': 'CONTACT', 'email': 'romfhd@ohsu.edu', 'phone': '503-494-4351'}, {'name': 'Winston Chamberlain, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Afshan Nanji, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Derek Louie, OD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yan Li, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Richard Stutzman, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Oregon Health & Science University, Casey Eye Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'Humberto Martinez, COT', 'role': 'CONTACT', 'email': 'martinhu@ohsu.edu', 'phone': '503-494-7712'}, {'name': 'Denzil Romfh, OD', 'role': 'CONTACT', 'email': 'romfhd@ohsu.edu', 'phone': '503-494-4351'}], 'overallOfficials': [{'name': 'David Huang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Peterson Professor of Ophthalmology & Professor of Biomedical Engineering', 'investigatorFullName': 'David Huang', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}