Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT06495112
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Lathe Cut Versus Cast Molding Soft Contact Lens Technique on Ocular Surface Integrity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003263', 'term': 'Contact Lenses, Hydrophilic'}], 'ancestors': [{'id': 'D003261', 'term': 'Contact Lenses'}, {'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2024-07-02', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal epithelial integrity', 'timeFrame': '12 Months', 'description': 'This involves assessing the health and integrity of the outermost layer of the cornea, which can be done through optical coherence tomography (OCT)'}, {'measure': 'Ocular surface symptoms', 'timeFrame': '12 months', 'description': 'Utilizing standardized questionnaires or scales to assess symptoms such as dryness, discomfort, or irritation experienced by the subjects wearing the different types of soft contact lenses.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ocular Surface Disease']}, 'descriptionModule': {'briefSummary': '"Comparison between Lathe Cut versus Cast Molding Soft Contact Lens Technique on Ocular Surface Integrity" investigates the impact of two different manufacturing methods on the health and integrity of the ocular surface.', 'detailedDescription': 'The study aims to determine which technique, lathe cutting or cast molding, produces soft contact lenses that are more biocompatible and less likely to cause adverse effects on the eye. The findings from our research could have significant implications for contact lens wearers and manufacturers, guiding the production of lenses that promote better ocular health and enhance wearer comfort. Ultimately, this research contributes valuable knowledge to optometry and ocular surface disease management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have never used contact lenses\n* Age of participants would be 15 to 35 years\n* Patients free of any ocular pathology\n\nExclusion Criteria:\n\n* Patients having astigmatism of more than 0.75DC\n* Subjects with a previous history of ocular surgery, eye pathology, or systemic disease.\n* Patients with abysmal compliance.'}, 'identificationModule': {'nctId': 'NCT06495112', 'briefTitle': 'Comparison Between Lathe Cut Versus Cast Molding Soft Contact Lens Technique on Ocular Surface Integrity', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Comparison Between Lathe Cut Versus Cast Molding Soft Contact Lens Technique on Ocular Surface Integrity', 'orgStudyIdInfo': {'id': 'MSRSW/Batch-Fall22/730'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Soft contact lens with lathe cut technique Lathe', 'interventionNames': ['Other: Soft contact lens with lathe cut technique Lathe']}, {'type': 'EXPERIMENTAL', 'label': 'Soft contact lens with cast molding technique', 'interventionNames': ['Diagnostic Test: Soft contact lens with cast molding technique']}], 'interventions': [{'name': 'Soft contact lens with lathe cut technique Lathe', 'type': 'OTHER', 'description': 'athe cut technique Lathe cutting involves shaping a solid block of lens material into the desired form using precision machinery. This method allows for customized lens designs but may result in a less smooth surface compared to cast molding. Cast molding, on the other hand, uses a liquid monomer that is cured in a mold to form the lens. This technique typically results in a smoother and more uniform lens surface.', 'armGroupLabels': ['Soft contact lens with lathe cut technique Lathe']}, {'name': 'Soft contact lens with cast molding technique', 'type': 'DIAGNOSTIC_TEST', 'description': "Participants in this arm would receive Cast molding soft contact lenses and would wear them according to the study protocol, also likely for a specified duration.The cast molding technique for soft contact lenses involves creating lenses by polymerizing a liquid monomer mixture within a mold that forms the desired lens shape. Here's a brief overview of the steps involved in the cast molding process", 'armGroupLabels': ['Soft contact lens with cast molding technique']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'The Keratoconus center, Eye 2 Eye Optometrists, 13 D valencia housing society', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}