Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
Study NCT ID:
NCT07208604
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-06
First Post:
2025-09-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open Label, Multi-center, Phase I Study of TECLens Quantitative Refractive Crosslinking in Presbyopia-Aged Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}, {'id': 'D009216', 'term': 'Myopia'}, {'id': 'D006956', 'term': 'Hyperopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-28', 'studyFirstSubmitDate': '2025-09-28', 'studyFirstSubmitQcDate': '2025-09-28', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduce refractive error', 'timeFrame': '3-months post procedure', 'description': 'Achieve manifest refraction outcome at 3 months post treatment within 0.75D of the pre-planned targeted refraction, in patients aged 40 to 65 years old'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Corneal crosslinking', 'Presbyopia', 'Myopia', 'Hyperopia'], 'conditions': ['Presbyopia']}, 'descriptionModule': {'briefSummary': "An 'on-eye' UV delivery system for corneal crosslinking can be used safely and effectively to help free presbyopic patients from the need for reading glasses.", 'detailedDescription': 'The clinical trial is evaluating the TECLens CXLens Crosslinking System, an investigational treatment using ultraviolet (UV) light (375 nm) with riboflavin (vitamin B2) to strengthen and reshape the cornea. By creating controlled biomechanical changes, this study aims to test whether the cornea can be reshaped to reduce refractive errors such as mild myopia or hyperopia in patients of presbyopic age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 40-65 years\n* Healthy cornea\n* Refractive error between +4.0 D and -5.0 D\n* Phakic or monofocal pseudophakic (≥6 months post IOL placement)\n* Visual acuity correctable by ±0.25 D\n\nExclusion Criteria:\n\n* Corneal dystrophy, scarring, or prior corneal crosslinking\n* Astigmatism \\>1.0 D\n* Active ocular infection, inflammation, or uncontrolled dry eye\n* Advanced glaucoma or diabetic retinopathy\n* History of delayed corneal healing\n* Pregnancy, breastfeeding, or planning pregnancy during study period\n* Certain medications (e.g., isotretinoin)\n* Recent participation in other investigational drug/device studies (within 30 days)\n* Patients with uncontrolled dry eye or surface disease'}, 'identificationModule': {'nctId': 'NCT07208604', 'briefTitle': 'Open Label, Multi-center, Phase I Study of TECLens Quantitative Refractive Crosslinking in Presbyopia-Aged Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'TECLens, Inc.'}, 'officialTitle': 'Open Label, Multi-center, Phase I Study of TECLens Corneal Crosslinking System for Correction of Refractive Error in Patients of Presbyopia Age.', 'orgStudyIdInfo': {'id': 'TEC-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Open label treatment arm', 'interventionNames': ['Device: Quantitative refractive crosslinking']}], 'interventions': [{'name': 'Quantitative refractive crosslinking', 'type': 'DEVICE', 'description': 'Non-invasive corneal cross-linking device delivering controlled UV light through a contact lens platform for biomechanical stabilization of the cornea.', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Makati City', 'state': 'Philippines', 'country': 'Philippines', 'contacts': [{'name': 'Mary Ann Catacutan', 'role': 'CONTACT', 'email': 'mtcatacutan@asianeyeinstitute.com', 'phone': '632-8898-2019'}], 'facility': 'Asian Eye Institute', 'geoPoint': {'lat': 14.55027, 'lon': 121.03269}}], 'centralContacts': [{'name': 'Patrick Lopath', 'role': 'CONTACT', 'email': 'plopath@teclens.com', 'phone': '919-824-5224'}, {'name': 'Ibrahim Seven', 'role': 'CONTACT', 'email': 'ibrahim.seven@teclens.com', 'phone': '440-485-9091'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TECLens, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Robert Ang, MD', 'class': 'UNKNOWN'}, {'name': 'Robert Ang, MD - Asian Eye Institute', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}