Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-26 @ 1:12 AM
Study NCT ID:
NCT05802550
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2023-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabo-lipidomics of the Ocular Surface for Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007368', 'term': 'Interferometry'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2023-03-13', 'studyFirstSubmitQcDate': '2023-03-24', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative ocular surface disease', 'timeFrame': '1 months after cataract surgery', 'description': 'Metabo-lipidomic analysis of intracellular content of the ocular surface preoperatively and aqueous humor intraoperatively to predict occurrence of ocular surface disease 1 month following cataract surgery.'}, {'measure': 'Postoperative ocular surface disease', 'timeFrame': '3 months after cataract surgery', 'description': 'Metabo-lipidomic analysis of intracellular content of the ocular surface preoperatively and aqueous humor intraoperatively to predict occurrence of ocular surface disease 3 months following cataract surgery.'}], 'secondaryOutcomes': [{'measure': 'Change in number and semi-quantitative concentrations of ocular surface metabolites', 'timeFrame': 'From baseline to 1 month after cataract surgery', 'description': 'Comparison of ocular surface metabolome using conjunctival impression cytology pre and postoperatively 1 month after cataract surgery'}, {'measure': 'Change in number and semi-quantitative concentrations of ocular surface lipids', 'timeFrame': 'From baseline to 1 month after cataract surgery', 'description': 'Comparison of ocular surface lipidome using conjunctival impression cytology pre and postoperatively 1 month after cataract surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ocular surface', 'Cataract', 'Conjunctival impression cytology', 'Aqueous humor', 'Metabolomic', 'Lipidomic'], 'conditions': ['Age-related Cataract']}, 'descriptionModule': {'briefSummary': "Cataract is the world's leading cause of blindness, the treatment of which, exclusively surgical, offers excellent results in terms of visual recovery. It represents the most frequently performed surgery in France with more than 800,000 procedures each year. However, some patients develop postoperative ocular surface disease that can affect final visual acuity and quality of life. For example, dry eye disease, very common in the elderly, can be worsened by cataract surgery.\n\nThe identification of ocular surface biomarkers predictive of the postoperative risk of ocular surface disease carries the promise of better personalized perioperative care.\n\nConjunctival impression cytology represents a rapid, minimally invasive method of collecting conjunctival cells, which has proven its usefulness in the evaluation of diseases of the ocular surface. The aqueous humor is directly accessible at the beginning of the surgery.\n\nAn approach combining ultra-high performance liquid chromatography coupled with high-resolution mass spectrometry on the cells of the ocular surface and on the aqueous humor could improve our understanding of the physiopathology of ocular surface disease following cataract surgery.\n\nThis study will aim to 1) search for prognostic biomarkers of ocular surface disease after cataract surgery using a metabo-lipidomic approach 2) improve our understanding of the pathophysiological mechanisms involved."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patient with cortico-nuclear and/or subcapsular cataract\n* Age \\> or = 50 years\n* Patient affiliated to a social security system\n* Patient agreeing to participate in the study who provided his/her free and informed written consent\n\nExclusion criteria:\n\n* History of ocular surgery or trauma (≤ 3 months)\n* Other types of cataract excepted age-related or diabetic cataract\n* Any eye drops or treatments that may interfere with the ocular surface\n* Lens wearer\n* Any general pathology with a known impact on the ocular surface (auto-immune disease, allergy)\n* Proven allergy to povidone-iodine or to a component of the postoperative treatment\n* Patient under legal protection (safeguard of justice, curatorship and guardianship), or in a situation of deprivation of freedom\n* Patient unable to understand the nature and objectives of the study'}, 'identificationModule': {'nctId': 'NCT05802550', 'acronym': 'CATARACTOMIQUE', 'briefTitle': 'Metabo-lipidomics of the Ocular Surface for Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Metabo-lipidomic Analysis of the Ocular Surface and Aqueous Humor for the Search of Predictive Biomarkers of Ocular Surface Disease After Cataract Surgery: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'DR220231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Longitudinal cohort study in cataract patients', 'description': 'Longitudinal, open-label, single-center cohort study in cataract patients.', 'interventionNames': ['Other: Ocular Surface Disease Index', 'Other: Interferometry', 'Other: Oxford score', 'Other: Conjunctival collection', 'Other: Aqueous humor collection', 'Other: Quantification of Tyndall and flare']}], 'interventions': [{'name': 'Ocular Surface Disease Index', 'type': 'OTHER', 'description': 'Questionnaire on ocular surface disorders', 'armGroupLabels': ['Longitudinal cohort study in cataract patients']}, {'name': 'Interferometry', 'type': 'OTHER', 'description': 'Non-contact examination measuring NIBUT (non-invasive break-up time), meibography and tear meniscus measurement', 'armGroupLabels': ['Longitudinal cohort study in cataract patients']}, {'name': 'Oxford score', 'type': 'OTHER', 'description': 'Investigation and quantification of superficial corneal punctate keratitis using the Oxford score', 'armGroupLabels': ['Longitudinal cohort study in cataract patients']}, {'name': 'Conjunctival collection', 'type': 'OTHER', 'description': 'Two conjunctival prints: one for metabolomic and one for lipidomic', 'armGroupLabels': ['Longitudinal cohort study in cataract patients']}, {'name': 'Aqueous humor collection', 'type': 'OTHER', 'description': 'Collection of 0.1 mL of aqueous humor immediately after making the accessory corneal incision at the beginning of the cataract surgery.', 'armGroupLabels': ['Longitudinal cohort study in cataract patients']}, {'name': 'Quantification of Tyndall and flare', 'type': 'OTHER', 'description': 'Quantification of Tyndall and flare (from 1 to 4 crosses) in anterior chamber', 'armGroupLabels': ['Longitudinal cohort study in cataract patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'RAOUL KANNAV KHANNA, MD', 'role': 'CONTACT', 'email': 'raoul.khanna@univ-tours.fr', 'phone': '02 47 47 27 67'}, {'name': 'RAOUL KANNAV KHANNA, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'PIERRE-JEAN PISELLA, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'HELENE BLASCO, PharmD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'PATRICK EMOND, PharmD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'SOPHIE CATANESE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'ANTOINE LEFEVRE, MEng', 'role': 'SUB_INVESTIGATOR'}, {'name': 'NATTIE LECOLIER, Msc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'KHANNA', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'RAOUL KANAV KHANNA', 'role': 'CONTACT', 'email': 'raoul.khanna@univ-tours.fr', 'phone': '02 47 47 27 67'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}