Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT04131335
Status:
UNKNOWN
Last Update Posted:
2019-10-18
First Post:
2019-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Prophylactic Lubricating Drops After Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 168}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-17', 'studyFirstSubmitDate': '2019-10-16', 'studyFirstSubmitQcDate': '2019-10-17', 'lastUpdatePostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction (CatPROM 5)', 'timeFrame': '6 weeks', 'description': 'Validated patient satisfaction questionnaire are used. Specially designed and validated conversion tables are used to convert raw scores from questionnaires to Rasch calibrated measures.'}, {'measure': 'Self-reported Health Outcome', 'timeFrame': '6 weeks', 'description': "A validated self-reported health questionnaire is used where a descriptive and vertical Visual Analogue Scale (VAS) are used. The descriptive scale assesses 5 domains at three levels of difficulty (no / some / extreme problems). The VAS is used to to record patients' self-reported health on a scale from 0-100 (100/100 being excellent health, 0/100 being very poor health."}, {'measure': 'Patient Reported Symptoms (Speed II questinnaire)', 'timeFrame': '6 weeks', 'description': 'A validated questionnaire is used with a grading system to grade severity of dry eye . symptoms. Score out of 28. Higher the score, the more significant the dry eye symptoms.'}], 'secondaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': '6 weeks'}, {'measure': 'Cornea and Conjunctival Staining Scores', 'timeFrame': '6 weeks', 'description': 'The Oxford Scale is used to grade staining of the conjunctiva and cornea. 0-5 (0 no staining, 5 significant staining).'}, {'measure': 'Schirmer 1 test', 'timeFrame': '6 weeks', 'description': 'Evaluation of aqueous tear production. Score of more than 10mm is normal. Less than 10mm indicates aqueous tear deficiency .'}, {'measure': 'Tear Break up Time', 'timeFrame': '6 weeks', 'description': 'Score of more than 10 seconds is normal. Less than 10 seconds indicates tear evaporative eye disease'}, {'measure': 'Cataract incision site and size', 'timeFrame': '6 weeks', 'description': 'Assess cataract incision size in relation to other tests and symptoms.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye', 'Cataract Surgery', 'Patient Related Outcome Measures', 'Patient Satisfaction']}, 'descriptionModule': {'briefSummary': 'This is a randomised controlled trial to assess the use of prophylactic lubricant eye-drops for 6 weeks following uncomplicated, routine cataract surgery to improve patient satisfaction and symptoms of dry eye, compared to controls.', 'detailedDescription': 'On entry into the study patients will be randomized to receive either lubricant eye-drops (phosphate-free, preservative-free lubricant eye drops containing 0.15% Sodium Hyaluronate with vitamins A and E (AEONTM Repair) to be administered four times a day for 6 weeks following surgery (in addition to the usual post-operative topical medications of Chloramphenicol 0.5 % eye drops for 1 week and topical dexamethasone 0.1% eyedrops (Maxidex) four times a day for 4 weeks) or no additional lubricant drops in addition to the usual medications described above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilateral or unilateral cataracts requiring surgical intervention\n* Age over 18 years\n* Able to understand informed consent and the objectives of the trial\n* Not pregnant, not breast feeding\n* No previous eye surgery\n\nExclusion Criteria:\n\n* age-related macula degeneration\n* glaucoma\n* previous retinal vascular disorders\n* previous retinal detachment or tear\n* any neuro-ophthalmological condition\n* any inherited retinal disorder or pathology\n* previous strabismus surgery or record of amblyopia\n* previous TIA, CVA or other vaso-occlusive disease\n* already enrolled in another study'}, 'identificationModule': {'nctId': 'NCT04131335', 'briefTitle': 'Use of Prophylactic Lubricating Drops After Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'Patient Satisfaction and Dry Symptoms in NHS Patients Undergoing Routine Uncomplicated Cataract Surgery Treated With Prophylactic Phosphate-free, Preservative-free Lubricant Eye Drops. A Randomised Controlled Prospective Study.', 'orgStudyIdInfo': {'id': '265860'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm', 'description': 'Experimental arm receives lubricant eye-drops (phosphate-free, preservative-free lubricant eye drops containing 0.15% Sodium Hyaluronate with vitamins A and E (AEONTM Repair) to be administered four times a day for 6 weeks following cataract surgery (in addition to the usual post-operative topical medications of Chloramphenicol 0.5 % eye drops for 1 week and topical dexamethasone 0.1% eyedrops (Maxidex) four times a day for 4 weeks).', 'interventionNames': ['Drug: AEONTM Repair', 'Other: Routine post-operative eye drops used.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm', 'description': 'The control arm group receive the usual post-operative topical medications of Chloramphenicol 0.5 % eye drops for 1 week and topical dexamethasone 0.1% eyedrops (Maxidex) four times a day for 4 weeks after cataract surgery.', 'interventionNames': ['Other: Routine post-operative eye drops used.']}], 'interventions': [{'name': 'AEONTM Repair', 'type': 'DRUG', 'description': 'Lubricating eye drops', 'armGroupLabels': ['Experimental Arm']}, {'name': 'Routine post-operative eye drops used.', 'type': 'OTHER', 'description': 'Dexamethasone 0.1% eye drops QDS for 4 weeks Chloramphenicol 0.5% eye drops QDS for 1 week', 'armGroupLabels': ['Control Arm', 'Experimental Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Dr Khayam Naderi, MBBS BSc MA', 'role': 'CONTACT', 'email': 'khayam.naderi@gstt.nhs.uk', 'phone': '020 7188 7188', 'phoneExt': '84331'}, {'name': "Prof David O'Brart, FRCOphth, MD", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St Thomas' Hospital NHS Trust London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Khayam Naderi, MBBS BSc MA', 'role': 'CONTACT', 'email': 'khayam.naderi@gstt.nhs.uk', 'phone': '020 7188 7188', 'phoneExt': '84331'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'collaborators': [{'name': 'City, University of London', 'class': 'OTHER'}, {'name': "King's College London", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}