Back to resultsComparison of Postoperative Aqueous Flare After 20G Versus 23G Pars Plana Vitrectomy (20Gvs23G)
Primary Purpose
Macular Hole, Macular Pucker
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
20G Vitrectomy
23G vitrectomy
Sponsored by
About this trial
This is an interventional basic science trial for Macular Hole
Eligibility Criteria
Inclusion Criteria:
age > 18 years macular hole macular pucker willing to perform follow up written signed consent
Exclusion Criteria:
other relevant eye disease: retinal detachment, provect cataract, diabetic retinopathy, AMD, relevant glaucoma, pre-surgery except for cataract surgery
Sites / Locations
- Center of Ophthalmology, University of Cologne
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
20G
23G
Arm Description
20G vitrectomy with scleral and conjunctival sutures for closure
23G transconjunctival sutureless vitrectomy
Outcomes
Primary Outcome Measures
Alteration of aqueous flare between preoperative and 3-week-postoperative time point
Secondary Outcome Measures
Visual acuity change
Closure of Macular hole
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01969929
Brief Title
Comparison of Postoperative Aqueous Flare After 20G Versus 23G Pars Plana Vitrectomy
Acronym
20Gvs23G
Official Title
Comparison of Postoperative Aqueous Flare After 20G Versus 23G Pars Plana Vitrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare postoperative inflammation and breakdown of blood-retinal barrier as measured by a laser flare-cell meter in 20G versus 23G vitrectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Hole, Macular Pucker
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
20G
Arm Type
Active Comparator
Arm Description
20G vitrectomy with scleral and conjunctival sutures for closure
Arm Title
23G
Arm Type
Active Comparator
Arm Description
23G transconjunctival sutureless vitrectomy
Intervention Type
Procedure
Intervention Name(s)
20G Vitrectomy
Intervention Type
Procedure
Intervention Name(s)
23G vitrectomy
Primary Outcome Measure Information:
Title
Alteration of aqueous flare between preoperative and 3-week-postoperative time point
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Visual acuity change
Time Frame
3 weeks
Title
Closure of Macular hole
Time Frame
3 weeks
Other Pre-specified Outcome Measures:
Title
Patient satisfaction
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 18 years macular hole macular pucker willing to perform follow up written signed consent
Exclusion Criteria:
other relevant eye disease: retinal detachment, provect cataract, diabetic retinopathy, AMD, relevant glaucoma, pre-surgery except for cataract surgery
Facility Information:
Facility Name
Center of Ophthalmology, University of Cologne
City
Cologne
State/Province
NRW
ZIP/Postal Code
50937
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
30448886
Citation
Scholz P, Muther PS, Schiller P, Felsch M, Fauser S. A Randomized Controlled Clinical Trial Comparing 20 Gauge and 23 Gauge Vitrectomy for Patients with Macular Hole or Macular Pucker. Adv Ther. 2018 Dec;35(12):2152-2166. doi: 10.1007/s12325-018-0826-6. Epub 2018 Nov 17.
Results Reference
derived
Learn more about this trial
Comparison of Postoperative Aqueous Flare After 20G Versus 23G Pars Plana Vitrectomy
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