Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-02-18 @ 3:17 AM
Study NCT ID:
NCT04403750
Status:
UNKNOWN
Last Update Posted:
2020-05-29
First Post:
2020-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Laser-surgical Technology of RRD Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-27', 'studyFirstSubmitDate': '2020-05-21', 'studyFirstSubmitQcDate': '2020-05-21', 'lastUpdatePostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal reattachment rate', 'timeFrame': 'in 1 month after gas resorption', 'description': 'complete retinal re-attachment'}], 'secondaryOutcomes': [{'measure': 'Anatomical success', 'timeFrame': '3, 6, 12 and 24 months post intervention', 'description': 'complete retinal re-attachment'}, {'measure': 'Visual acuity', 'timeFrame': '3, 6, 12 and 24 months post intervention', 'description': 'ETDRS'}, {'measure': 'Visual acuity', 'timeFrame': '3, 6, 12 and 24 months post intervention', 'description': 'Snellen'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rhegmatogenous Retinal Detachment']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Bayzulaeva M.R., Doga A.V., Shkvorchenko D.O., Kryl L.A., Buryakov D.A. [Assessment of peripheral vitreoretinal interface structural changes in patients with local rhematogenous retinal detachments by wide-field optical coherent tomography]. Modern technologies in ophtalmology. 2019 June 25. doi: https://doi.org/10.25276/2312-4911-2019-4-20-23'}, {'type': 'BACKGROUND', 'citation': 'Doga A.V., Shkvorchenko D.O., Kryl L.A., Buryakov D.A., Bayzulaeva M.R. [The assessment of combined laser and microinvasive surgery efficiency in local retinal detachment treatment]. Modern technologies in ophtalmology. 2019 March 20. doi: https://doi.org/10.25276/2312-4911-2019-1-363-368'}], 'seeAlsoLinks': [{'url': 'https://eyepress.ru/article.aspx?40421', 'label': 'Assessment of peripheral vitreoretinal interface structural changes in patients with local rhematogenous retinal detachments by wide-field optical coherent tomography'}, {'url': 'https://eyepress.ru/article.aspx?30058', 'label': 'The assessment of combined laser and microinvasive surgery efficiency in local retinal detachment treatment'}]}, 'descriptionModule': {'briefSummary': 'Purpose: to assess the efficacy and safety of combined laser-surgical technology of RRD treatment', 'detailedDescription': 'The study takes place in the S.N. Fyodorov "Eye Microsurgery" Federal State Institution located in Moscow, Russian Federation.\n\nThe study will include 50 patients with rhegmatogenous retinal detachment due to a horseshoe-tear. In addition to the standard ophthalmological examination, all patients will undergo wide-field optical coherence tomography to determine the extension and localization of the vitreoretinal traction zone. The obtained data will be used to planning the 1st step of laser-surgical treatment. All patients will undergo a combined laser-surgical technology, which includes 3 steps: 1) Nd-YAG laser excision of the vitreoretinal traction zone 2) pneumatic retinopexy (10% C3F8) 3) barrier laser photocoagulation around retinal break after retinal attachment.\n\nThe patients are going to be followed up for at least 1 year, the main outcome measures are postoperative primary and final anatomic outcome, BCVA and complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Rhegmatogenous retinal detachment extending from the 9-o'clock to the 3-o'clock meridians.\n2. Superior retinal break from 9 o'clock to 3 o'clock\n3. Single retinal break not greater than 1 clock hours in size\n4. Physically and mentally co-operated in post-operative head positioning\n5. No (or minimal) proliferative vitreoretinopathy\n6. None or mild vitreous hemorrhage.\n\nExclusion Criteria:\n\n1. Severe concomitant eye pathologies (glaucoma, diabetic retinopathy, macular hole, traumas); OR\n2. Ocular media opacities\n3. Previous ocular surgeries\n4. Age \\<18 years\n5. Previous retinal detachment (index eye)"}, 'identificationModule': {'nctId': 'NCT04403750', 'briefTitle': 'Combined Laser-surgical Technology of RRD Treatment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The S.N. Fyodorov Eye Microsurgery State Institution'}, 'officialTitle': 'Combined Laser-surgical Technology of Rhegmatogenous Retinal Detachment Treatment', 'orgStudyIdInfo': {'id': 'Technology of RRD treatment'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combined laser-surgical technology', 'description': 'Combined laser-surgical technology includes 3 steps:\n\n1. Nd-YAG laser excision of the vitreoretinal traction zone\n2. Pneumatic retinopexy (10% C3F8)\n3. Barrier laser photocoagulation around retinal break after retinal attachment.', 'interventionNames': ['Procedure: Combined laser-surgical technology of RRD treatment']}], 'interventions': [{'name': 'Combined laser-surgical technology of RRD treatment', 'type': 'PROCEDURE', 'description': '1. Nd-YAG laser excision of the vitreoretinal traction zone\n2. Pneumatic retinopexy (10% C3F8)\n3. barrier laser photocoagulation around retinal break after retinal attachment (2-3 days after pneumatic retinopexy)', 'armGroupLabels': ['Combined laser-surgical technology']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Mariiam Taevere', 'role': 'CONTACT', 'phone': '+79160173038'}, {'name': 'Leonid Kryl, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mariiam Taevere, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The S.N. Fyodorov Eye Microsurgery State Institution.', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Mariiam Taevere, MD', 'role': 'CONTACT', 'email': 'taeveremr@gmail.com', 'phone': '+79160173038'}, {'name': 'Leonid Kryl, PhD, MD', 'role': 'CONTACT', 'email': 'doctor-leonid@inbox.ru', 'phone': '+79163747142'}], 'overallOfficials': [{'name': 'Leonid Kryl, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'S.N. Fyodorov Eye Microsurgery State Institution.'}, {'name': 'Mariiam Taevere, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'S.N. Fyodorov Eye Microsurgery State Institution.'}, {'name': 'Alexander Doga, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'S.N. Fyodorov Eye Microsurgery State Institution.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The S.N. Fyodorov Eye Microsurgery State Institution', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Taevere M.R', 'investigatorAffiliation': 'The S.N. Fyodorov Eye Microsurgery State Institution'}}}}