Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-29 @ 10:47 AM
Study NCT ID:
NCT06914232
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-06
First Post:
2025-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Warm Compress Therapy in Enhancing Tear Film Quality and Reducing Postoperative DES
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-29', 'studyFirstSubmitDate': '2025-03-29', 'studyFirstSubmitQcDate': '2025-03-29', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Surface Disease Index (OSDI)', 'timeFrame': '12 Months', 'description': 'The Ocular Surface Disease Index (OSDI) is a 12-question questionnaire used to assess the severity of dry eye symptoms and their impact on vision-related function, scored on a scale of 0 to 100, with higher scores indicating greater disability.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndrome']}, 'descriptionModule': {'briefSummary': 'Dry eye disease (DED) is a multifactorial condition often exacerbated by cataract surgery, leading to discomfort and visual disturbances. Meibomian gland dysfunction (MGD), a key cause of DED, contributes to tear film instability, which can be managed with warm compress therapy.', 'detailedDescription': 'This study aims to evaluate the effectiveness of perioperative warm compress therapy (TPT) in improving tear film stability and reducing dry eye symptoms following cataract surgery. This randomized controlled trial (RCT) will involve 54 patients with estimated attrition rate 60 participants aged 50-70 with moderate to severe dry eye symptoms and tear film instability, as indicated by high Ocular Surface Disease Index (OSDI) scores. Participants will be randomly assigned to either an intervention group, receiving warm compress therapy before and after surgery, or a control group receiving standard dry eye treatments for 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 30 to 70 years\n* Patients scheduled for cataract surgery (both unilateral and bilateral).\n* Patients with preoperative moderate to severe dry eye symptoms, which will be assessed using the Ocular Surface Disease Index (OSDI).\n\nExclusion Criteria:\n\n* Patients with OSDI, indicating severe dry eye disease which suggests severe dry eye disease. These patients might require more intensive treatments beyond Warm Compress therapy.\n* Patients with systemic diseases (e.g., rheumatoid arthritis, lupus) that affect tear production or who are using medications that severely reduce tear production (e.g., chronic use of antihistamines or systemic corticosteroids).\n* Patients with significant pre-existing corneal pathology (e.g., corneal dystrophies, corneal scars) that could affect the results of cataract surgery or thermal pulsation therapy.\n* Patients with active ocular infections (e.g., conjunctivitis, keratitis) or inflammation at the time of screening or surgery.\n* Patients with a history of previous ocular surgeries (excluding cataract surgery) in the study eye, such as refractive surgery (LASIK, PRK) or corneal transplants.\n* Patients with a known allergy or contraindication to Warm Compress therapy or its components.'}, 'identificationModule': {'nctId': 'NCT06914232', 'briefTitle': 'Efficacy of Warm Compress Therapy in Enhancing Tear Film Quality and Reducing Postoperative DES', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Efficacy of Warm Compress Therapy in Enhancing Tear Film Quality and Reducing Postoperative Dry Eye Syndrome After Cataract Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MSRSW/Batch-Fall23/817'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Warm Compress', 'interventionNames': ['Combination Product: Warm Compress']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', 'interventionNames': ['Diagnostic Test: Standard Care']}], 'interventions': [{'name': 'Warm Compress', 'type': 'COMBINATION_PRODUCT', 'description': 'The intervention involves perioperative Warm compress therapy administered to the participants in the intervention group before and after cataract surgery for 3 seesions per week for 6 weeks. The therapy aims to enhance tear film stability and alleviate symptoms of dry eye by delivering warm compress to the meibomian glands to restore their function. Participants will undergo a session of warm compress therapy prior to surgery and another one following the surgery.', 'armGroupLabels': ['Warm Compress']}, {'name': 'Standard Care', 'type': 'DIAGNOSTIC_TEST', 'description': 'The control group will receive standard care, which includes artificial tears or other conventional methods for dry eye management for 3 sessions per week for 6 weeks. , but they will not receive Warm Compress therapy.', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chak Two Hundred Fourteen', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Hakeem mahmood trust hospital address alam chowk mean baipas', 'geoPoint': {'lat': 31.29188, 'lon': 72.53995}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}