Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-01 @ 8:17 AM
Study NCT ID:
NCT04333069
Status:
UNKNOWN
Last Update Posted:
2020-04-03
First Post:
2020-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of Cataract Surgery With Uveitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D014605', 'term': 'Uveitis'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-01', 'studyFirstSubmitDate': '2020-03-28', 'studyFirstSubmitQcDate': '2020-04-01', 'lastUpdatePostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'final postoperative uncorrected visual acuity (UCVA)', 'timeFrame': '1 week post operative', 'description': 'post operative uncorrected visual acuity which mean visual acuity without spectacle correction'}, {'measure': 'final postoperative uncorrected visual acuity (UCVA)', 'timeFrame': '1month post operative', 'description': 'post operative uncorrected visual acuity which mean visual acuity without spectacle correction'}, {'measure': 'final postoperative uncorrected visual acuity (UCVA)', 'timeFrame': '3months post operative', 'description': 'post operative uncorrected visual acuity which mean visual acuity without spectacle correction'}, {'measure': 'final postoperative uncorrected visual acuity (UCVA)', 'timeFrame': '6months post operative', 'description': 'post operative uncorrected visual acuity which mean visual acuity without spectacle correction'}, {'measure': 'Final post operative best corrected visual acuity (BCVA)', 'timeFrame': '1 week post operative', 'description': 'Post operative visual acuity with spectacle correction'}, {'measure': 'Final post operative best corrected visual acuity (BCVA)', 'timeFrame': '1month post operative', 'description': 'Post operative visual acuity with spectacle correction'}, {'measure': 'Final post operative best corrected visual acuity (BCVA)', 'timeFrame': '3months post operative', 'description': 'Post operative visual acuity with spectacle correction'}, {'measure': 'Final post operative best corrected visual acuity (BCVA)', 'timeFrame': '6months post operative', 'description': 'Post operative visual acuity with spectacle correction'}], 'secondaryOutcomes': [{'measure': 'incidence of postoperative complications', 'timeFrame': '6 months post operative', 'description': 'cystoid macular edema which mean inflammation, swelling and collection of fluid inside macula) .'}, {'measure': 'Reactivation of intraocular inflammation', 'timeFrame': '6 months post operative', 'description': 'Appearance of inflammatory activity inside the eye after period of quiescence of at least 6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['uveitis'], 'conditions': ['Cataract; Complicata']}, 'referencesModule': {'references': [{'pmid': '32157612', 'type': 'BACKGROUND', 'citation': 'Carpentier SJ, Jung JL, Patnaik JL, Pecen PE, Palestine AG. A Cross-Sectional Online Survey Identifies Subspecialty Differences in the Management of Pediatric Cataracts Associated with Uveitis. Ophthalmol Ther. 2020 Jun;9(2):293-303. doi: 10.1007/s40123-020-00245-x. Epub 2020 Mar 10.'}, {'pmid': '31788579', 'type': 'BACKGROUND', 'citation': 'Chen JL, Bhat P, Lobo-Chan AM. Perioperative Management of Uveitic Cataracts. Adv Ophthalmol Optom. 2019 Aug;4:325-339. doi: 10.1016/j.yaoo.2019.04.014. Epub 2019 May 18.'}, {'pmid': '30900580', 'type': 'BACKGROUND', 'citation': 'Yangzes S, Seth NG, Singh R, Gupta PC, Jinagal J, Pandav SS, Gupta V, Gupta A, Ram J. Long-term outcomes of cataract surgery in children with uveitis. Indian J Ophthalmol. 2019 Apr;67(4):490-495. doi: 10.4103/ijo.IJO_846_18.'}, {'pmid': '30574896', 'type': 'BACKGROUND', 'citation': 'Jinagal J, Gupta G, Agarwal A, Aggarwal K, Akella M, Gupta V, Suri D, Gupta A, Singh S, Ram J. Safety and efficacy of dexamethasone implant along with phacoemulsification and intraocular lens implantation in children with juvenile idiopathic arthritis associated uveitis. Indian J Ophthalmol. 2019 Jan;67(1):69-74. doi: 10.4103/ijo.IJO_713_18.'}, {'pmid': '30203671', 'type': 'BACKGROUND', 'citation': 'El Gharbawy SA, Darwish EA, Abu Eleinen KG, Osman MH. Efficacy of addition of nepafenac 0.1% to steroid eye drops in prevention of post-phaco macular edema in high-risk eyes. Eur J Ophthalmol. 2019 Jul;29(4):453-457. doi: 10.1177/1120672118799626. Epub 2018 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'Aim of the study is to evaluate outcome of cataract surgery in different types of uveitis as regarding best corrected visual acuity (BCVA) and rate of post operative complications.', 'detailedDescription': 'Cataract is the main cause of reversible blindness in patients with uveitis. Cataract occurs in up to 50% to 70% of patients with uveitis.\n\nPreoperative complications, including anterior synechiae, posterior synechiae, and pupillary membrane formation, may increase surgical challenges. In addition, recurrent inflammation increases the incidence of postoperative complications and often affects the visual prognosis. In recent years, phacoemulsification with intra ocular lens (IOL)implantation has become the main surgical method for treating uveitis (complicated cataract), and the visual prognosis of patients who undergo this procedure is usually favorable.\n\nSurgical treatment may be effective but is associated with higher rates of complication than in non uveitic eyes. Cystoid macular edema (CME) is the most common complication cataract surgery in the general population. Although, in most cases, the macular edema is self-limited, in rare cases it can lead to long-term visual deterioration that is difficult to treat.\n\nAnother common complication after cataract surgery is posterior capsule opacification (PCO) , leading to symptoms of glare or blurred vision, reduced visual acuity, or impaired posterior segment exam. Factors that are critical in the development of PCO include surgical technique, type of implanted intra ocular lens (IOL) either foldable hydrophilic acrylic, hydrophobic acrylic or silicone and postoperative control of uveitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Visually significant cataract ( means opacification of the crystalline lens adequate to interfere with vision)in patients with uveitis controlled for at least 1month.\n\nExclusion Criteria:\n\n* Irreversible pathology affecting outcome e.g. macular scar ,optic atrophy, and retinal detachment.\n* Patients with active uveitis (means inflammation inside the eye).\n* Patients less than 16 years old.'}, 'identificationModule': {'nctId': 'NCT04333069', 'briefTitle': 'Outcome of Cataract Surgery With Uveitis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Outcome of Cataract Surgery in Patient With Uveitis', 'orgStudyIdInfo': {'id': 'cat in uveitic patients'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Uncorrected and best corrected visual acuity', 'description': 'Measuring of uncorrected and best corrected visual acuity after phaco emulsification and irrigation aspiration cataract surgery', 'interventionNames': ['Procedure: cataract surgery']}], 'interventions': [{'name': 'cataract surgery', 'type': 'PROCEDURE', 'description': 'cataract surgery in form of phaco emulsification or irrigation aspiration', 'armGroupLabels': ['Uncorrected and best corrected visual acuity']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mona Abdallah Abd AlRazik Ahmed, MD', 'role': 'CONTACT', 'email': 'monaabdallah51290@aun.edu.eg', 'phone': '01014398129'}, {'name': 'Mohammed Gamal Saleh, lecturer', 'role': 'CONTACT', 'email': 'mgsaleh05@yahoo.com', 'phone': '01004530716'}], 'overallOfficials': [{'name': 'Ashraf Khalaf Al Husseini, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Wael Mohammed Ahmed Soliman, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer at Ophthalmology departmentAssiut University Faculty of Medicine', 'investigatorFullName': 'Mona Abdallah Abdal Razik Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}