Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-07 @ 6:04 AM
Study NCT ID:
NCT06896357
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-26
First Post:
2025-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Limbal Relaxing Incisions for Correcting Post Phacoemulsification High Astigmatism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2025-03-17', 'studyFirstSubmitQcDate': '2025-03-24', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual acuity improvement', 'timeFrame': '3 months', 'description': 'assessment the improvement in visual acuity ,which will be measured by Landolt Cs chart with decimal notation.'}, {'measure': 'contrast sensitivity improvement', 'timeFrame': '3 months', 'description': 'Assessment the improvement in contrast sensitivity using Pelli-Robson contrast sensitivity test .'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Astigmatism', 'Phacoemulsification']}, 'referencesModule': {'references': [{'pmid': '28482825', 'type': 'BACKGROUND', 'citation': 'Li Z, Han Y, Hu B, Du H, Hao G, Chen X. Effect of Limbal relaxing incisions during implantable collamer lens surgery. BMC Ophthalmol. 2017 May 8;17(1):63. doi: 10.1186/s12886-017-0458-7.'}, {'type': 'BACKGROUND', 'citation': 'Rashwan A, Natag A, Wasfi E, Lotfy H, Shehata MJDJoO. Manually performed limbal relaxing incisions versus femtosecond laser-guided astigmatic keratotomy for correction of corneal astigmatism after phacoemulsification. 2024;25(3):150-5'}, {'type': 'BACKGROUND', 'citation': 'OAM SWJUJoO. Managing Corneal Astigmatism. 2023;11(03):78-82'}, {'pmid': '21840163', 'type': 'BACKGROUND', 'citation': 'Khan MI, Muhtaseb M. Prevalence of corneal astigmatism in patients having routine cataract surgery at a teaching hospital in the United Kingdom. J Cataract Refract Surg. 2011 Oct;37(10):1751-5. doi: 10.1016/j.jcrs.2011.04.026. Epub 2011 Aug 12.'}, {'pmid': '19101427', 'type': 'BACKGROUND', 'citation': 'Ferrer-Blasco T, Montes-Mico R, Peixoto-de-Matos SC, Gonzalez-Meijome JM, Cervino A. Prevalence of corneal astigmatism before cataract surgery. J Cataract Refract Surg. 2009 Jan;35(1):70-5. doi: 10.1016/j.jcrs.2008.09.027.'}, {'pmid': '31166427', 'type': 'BACKGROUND', 'citation': 'Theiss MB, Santhiago MR, Moraes HV Jr, Gomes BF. Prevalence of corneal astigmatism in cataract surgery candidates at a public hospital in Brazil. Arq Bras Oftalmol. 2019 Jun 3;82(5):377-380. doi: 10.5935/0004-2749.20190071.'}, {'pmid': '35204334', 'type': 'BACKGROUND', 'citation': 'Khoramnia R, Auffarth G, Labuz G, Pettit G, Suryakumar R. Refractive Outcomes after Cataract Surgery. Diagnostics (Basel). 2022 Jan 19;12(2):243. doi: 10.3390/diagnostics12020243.'}]}, 'descriptionModule': {'briefSummary': 'To compare the effect of Limbal relaxing incisions (LRIs) plus spectacle correction versus spectacle correction alone on subjective and objective improvement in visual function for correcting post phacoemulsification high astigmatism .', 'detailedDescription': 'Astigmatism is one of the commonest refractive errors encountered during our clinical practice. Surgically induced astigmatism is the main obstacle to achieve good uncorrected visual acuity following cataract surgery. It is estimated that corneal astigmatism of more than 1.0 diopter (D) is found in up to 40% of patients presenting for cataract surgery, 1.5D or more is present in over 20% and above 2.0D in 10%.\n\nAstigmatism induces distortion of the image leading to compromise quality of vision. In order to achieve better visual results, the effect of postoperative astigmatism should be minimized, management options for corneal astigmatism include glasses, contact lenses, and surgery such as Limbal relaxing incisions (LRIs), refractive laser surgery, toric lenses or rarely corneal grafting. The LRIs technique involves the placement of incisions corresponding to the steep meridian, resulting in corneal flattening and the reduction of astigmatic power. LRI is a safe and an inexpensive procedure, which is simple for experts to perform. Although most of the nomograms recommended that LRIs technique can correct up to 3 D of astigmatism ,it has been found that it is possible to correct even more than 4 D if the incisions were performed on high degrees of astigmatism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Conventional phacoemulsification was done at least one month earlier.\n* Clear cornea with corneal astigmatism more than 3.0 D.\n\nExclusion Criteria:\n\n* History of corneal surgeries (e.g., keratoplasty, refractive surgery, and corneal wound repair).\n* Ocular trauma.\n* Other intraocular surgery.\n* Patient with corneal opacities.\n* Thin cornea .\n* Any significant ocular disease causing diminution of vision (e.g., optic atrophy, diabetic retinopathy, and age-related macular degeneration), autoimmune disease, and peripheral corneal disease.'}, 'identificationModule': {'nctId': 'NCT06896357', 'briefTitle': 'Effectiveness and Safety of Limbal Relaxing Incisions for Correcting Post Phacoemulsification High Astigmatism', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effectiveness and Safety of Limbal Relaxing Incisions for Correcting Post Phacoemulsification High Astigmatism', 'orgStudyIdInfo': {'id': 'LRIs in high astigmatism'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with post phacoemulsification high astigmatism .', 'interventionNames': ['Procedure: Limbal relaxing incisions']}], 'interventions': [{'name': 'Limbal relaxing incisions', 'type': 'PROCEDURE', 'description': 'A fixed depth diamond-guarded knife (Gemcision LRI 600 Microns Blade, Katalyst Surgical, chesterfield, MO, USA) will be used to create a paired circumferential corneal incision, following the limbal curvature, 1-1.5mm anterior to the limbus centered on the steep corneal meridian. The incision arc length will be ninety degree according to the Nichamin Age and Pachymetry Adjusted (NAPA) nomogram.', 'armGroupLabels': ['patients with post phacoemulsification high astigmatism .']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'youstina shaheir gad, resident doctor', 'role': 'CONTACT', 'email': 'youstina.shaheir22@gmail.com', 'phone': '+2088234-1993'}], 'overallOfficials': [{'name': 'Ehab Ismail Ahmed, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}, {'name': 'Hani Omar Elsodafy, Assistant Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}, {'name': 'Sara Hussein Mohamed, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor of ophthalmology', 'investigatorFullName': 'Youstina shaheir shawky gad', 'investigatorAffiliation': 'Assiut University'}}}}