Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-28 @ 4:42 AM
Study NCT ID:
NCT04360603
Status:
UNKNOWN
Last Update Posted:
2020-04-24
First Post:
2020-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety Outcomes of 27 Gauge Vitrectomy for Posterior Segment Disease in High Myopia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-22', 'studyFirstSubmitDate': '2020-04-19', 'studyFirstSubmitQcDate': '2020-04-22', 'lastUpdatePostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'total vitrectomy time', 'timeFrame': 'during operation', 'description': 'total vitrectomy time'}, {'measure': 'total surgical time', 'timeFrame': 'during operation', 'description': 'total surgical time'}, {'measure': 'visual outcomes', 'timeFrame': 'post-operation month 1, 3, 6', 'description': 'best-corrected visual acuity and visual acuity changes'}, {'measure': 'Incidence of anatomical success', 'timeFrame': 'post-operation month 1, 3, 6', 'description': 'anatomical success, such as restoration of normal foveal contour, reattachment of retina'}], 'primaryOutcomes': [{'measure': 'Incidence of intraoperative sclerotomy site wound leakage', 'timeFrame': 'immediately at the end of surgery', 'description': 'The incidence of intraoperative sclerotomy site wound leakage'}], 'secondaryOutcomes': [{'measure': 'Incidence of postoperative sclerotomy site wound leakage', 'timeFrame': 'post-operation day 1, 3, week 1, month 1, 3, 6', 'description': 'postoperative complication'}, {'measure': 'Incidence of hypotony', 'timeFrame': 'post-operation day 1, 3, week 1, month 1, 3, 6', 'description': 'intraoperative and postoperative complication'}, {'measure': 'Incidence of endophthalmitis', 'timeFrame': 'post-operation day 1, 3, week 1, month 1, 3, 6', 'description': 'postoperative complication'}, {'measure': 'Incidence of instrument bending', 'timeFrame': 'during operation', 'description': 'intraoperative complications'}, {'measure': 'Incidence of subconjunctival hemorrhage', 'timeFrame': 'post-operation day 1, 3, week 1, month 1, 3, 6', 'description': 'postoperative complication'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['vitrectomy', 'high myopia', 'wound leakage'], 'conditions': ['Wound Complication', 'High Myopia', 'Vitrectomy']}, 'descriptionModule': {'briefSummary': 'In recent decade, a major improvement in vitreoretinal surgery was the use of small gauge surgical systems that improved the safety of vitrectomy and also reduced the surgical time. However, there were still some concerns regarding small gauge vitrectomy system, especially 27-gauge system, in the stability of its instruments and the efficacy of removing vitreous during surgery. Although there were some studies that had reported the surgical outcomes of 27G vitrectomy system, none had focused on patients with high myopia. The highly myopic patients usually had thinner sclera, which was a risk factor for wound leakage after sutureless vitrectomy, they also had longer axial length which would make the surgical procedure more difficult especially in macular surgery.\n\nBased on previous clinical finding, gas leakage was 36.4% in 25G , while 27G sclerotomy showing less leakage comparing to larger gauge sclerotomy, the investigators believe 27G may have its clinical advantages in overcoming the thinner sclera of high myopia, and show the superiority of leakage control.\n\nHypothesis:\n\nThe 27G vitrectomy system has lower sclerotomy wound leakage rate compared with 25G system'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Highly myopic patients (axial length 26\\~31mm)\n2. Diagnosed with vitreoretinal pathology that require vitrectomy\n3. Never received vitrectomy before\n\nExclusion criteria:\n\n1. Surgical planning including scleral buckling during operation\n2. Surgical planning including combined phacoemulsification\n3. Surgical planning including the use of silicone oil and/or perfluorocarbon liquid\n4. Previous ocular surgery involving conjunctival manipulation and scarring such as pterygium removal/trabeculectomy\n5. Previous vitrectomy\n6. Previous ocular trauma involving corneal/corneoscleral/scleral/conjunctival full thickness laceration\n7. Medical history with known connective tissue disease(s)\n8. Age younger than 20 years old'}, 'identificationModule': {'nctId': 'NCT04360603', 'briefTitle': 'The Safety Outcomes of 27 Gauge Vitrectomy for Posterior Segment Disease in High Myopia', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Safety Outcomes of 27 Gauge Vitrectomy for Posterior Segment Disease in High Myopia', 'orgStudyIdInfo': {'id': '201907025RINB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '27 gauge system', 'description': 'study group, using 27G vitrectomy system', 'interventionNames': ['Device: 27G']}, {'type': 'ACTIVE_COMPARATOR', 'label': '25 gauge system', 'description': 'control group, using 25G vitrectomy system', 'interventionNames': ['Device: 25G']}], 'interventions': [{'name': '27G', 'type': 'DEVICE', 'description': 'using 27G vitrectomy system to perform standard transconjunctival sutureless vitrectomy', 'armGroupLabels': ['27 gauge system']}, {'name': '25G', 'type': 'DEVICE', 'description': 'using 25G vitrectomy system to perform standard transconjunctival sutureless vitrectomy', 'armGroupLabels': ['25 gauge system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'contacts': [{'name': 'Chung-May Yang', 'role': 'CONTACT', 'email': 'chungmay@ntu.edu.tw', 'phone': '分機:65187；GSM:51547'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Tso-Ting Lai, MD', 'role': 'CONTACT', 'email': 'b91401005@ntu.edu.tw', 'phone': '0972651992'}, {'name': 'Yi-Ting Hsieh, MD, PhD', 'role': 'CONTACT', 'email': 'ythyth@gmail.com', 'phone': '0972655018'}], 'overallOfficials': [{'name': 'Chung-May Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}