Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-30 @ 9:13 AM
Study NCT ID:
NCT05265832
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2022-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influencing Factors of the Corneal Endothelial Cell Loss
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': 'D018918', 'term': 'Phacoemulsification'}], 'ancestors': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-20', 'studyFirstSubmitDate': '2022-02-23', 'studyFirstSubmitQcDate': '2022-02-23', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative endothelial cell loss', 'timeFrame': 'Month 3', 'description': 'Difference in endothelial cell density between preoperative measurements and 3 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endothelial cell loss'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'This is a multi-center cohort study with prognostic aims to identify factors associated with endothelial cell loss during cataract surgery.\n\nPatients will have their endothelial density measured by specular microscopy preoperatively, at 1 month and at 3 months after surgery. The rest of their management will be in line with standard practice.', 'detailedDescription': 'Cataract surgery is the most commonly performed surgical procedure worldwide. Postoperative visual function depends on implant into the crystalline lens, retinal lesion, corneal damage or glaucomatous damage. Moreover, preoperative corneal endothelial damage should be as low as possible to provide corneal transparency. Indeed, the endothelium plays important role in maintaining corneal transparency.\n\nThe loss rate of endothelial cell after cataract surgery ranges in the scientific literature from 8 to 15 %. Severe endothelial cell loss contributes to corneal edema. This edema resulting in a loss of visual acuity and may require corneal transplantation as a last resort.\n\nVarious studies describe some factors that affecting endothelial cell loss such as the cataract density, pupil abnormalities (small diameter), Advanced age or short axial length.\n\nHowever, few studies have been demonstrated the link between endothelial cell loss and the volume of fluid used during the intervention or the use of intracamerular substances. This study wants to establish a correlation between endothelial cell loss and predictive factors. Thus, knowledge of these factors would have ensured a better control of endothelial dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing cataract surgery\n* Visual acuity monoyer scale \\<8/10e (\\> +0.2 logMar)\n* Nuclear, cortical and posterior subcapsular cataract with normal density to severe in the LOCSIII classification\n* Covered by the social security scheme\n* Have given their oral agreement\n\nExclusion Criteria:\n\n* Corneal disease: keratitis, dystrophy or corneal degeneration\n* Any disease of the anterior segment\n* Low preoperative endothelial cell density \\<1000 c/mm²\n* Pregnancy, lactation\n* Risk factors for surgical per-operative complication\n* Uncontrolled ocular pressure\n* Combined surgery (cataract with corneal graft, cataract with glaucoma surgery, cataract with vitrectomy, ....)\n* Under legal protection'}, 'identificationModule': {'nctId': 'NCT05265832', 'acronym': 'PREDICS', 'briefTitle': 'Influencing Factors of the Corneal Endothelial Cell Loss', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Régional Metz-Thionville'}, 'officialTitle': 'Identification of Factors That Influence the Corneal Endothelial Cell Loss During Phacoemulsification', 'orgStudyIdInfo': {'id': '2021-04-CHRMT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cataract surgery', 'description': 'Phacoemulsification cataract surgery', 'interventionNames': ['Procedure: Phacoemulsification']}], 'interventions': [{'name': 'Phacoemulsification', 'type': 'PROCEDURE', 'description': 'Endocapsular technique (Divide-and-conquer) and supracapsular technique (Subluxation) will be used equally.', 'armGroupLabels': ['Cataract surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57085', 'city': 'Metz', 'state': 'Grand Est', 'country': 'France', 'facility': 'CHR Metz-Thionville/Hopital Mercy', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'city': 'Thionville', 'state': 'Grand Est', 'country': 'France', 'facility': 'CHR Metz-Thionville_Hopital Bel Air', 'geoPoint': {'lat': 49.35994, 'lon': 6.16044}}], 'overallOfficials': [{'name': 'Jean Marc Perone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Metz Thionville Hopital de Mercy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}