20Gvs23G: Comparison of Postoperative Aqueous Flare After 20G Versus 23G Pars Plana Vitrectomy
Sponsor
University of Cologne (Other)
Overall Status
Unknown status
CT.gov ID
NCT01969929
Collaborator
(none)
100
1
2
24
4.2
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Comparison of Postoperative Aqueous Flare After 20G Versus 23G Pars Plana Vitrectomy
Study Start Date
:
Oct 1, 2013
Anticipated Primary Completion Date
:
Oct 1, 2015
Anticipated Study Completion Date
:
Oct 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 20G 20G vitrectomy with scleral and conjunctival sutures for closure |
Procedure: 20G Vitrectomy
|
| Active Comparator: 23G 23G transconjunctival sutureless vitrectomy |
Procedure: 23G vitrectomy
|
Outcome Measures
Primary Outcome Measures
- Alteration of aqueous flare between preoperative and 3-week-postoperative time point [3 weeks]
Secondary Outcome Measures
- Visual acuity change [3 weeks]
- Closure of Macular hole [3 weeks]
Other Outcome Measures
- Patient satisfaction [3 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center of Ophthalmology, University of Cologne | Cologne | NRW | Germany | 50937 |
Sponsors and Collaborators
- University of Cologne
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Sascha Fauser,
MD, PhD,
University of Cologne
ClinicalTrials.gov Identifier:
NCT01969929
Other Study ID Numbers:
- UKK-13-247
- 13-247
First Posted:
Oct 25, 2013
Last Update Posted:
Jun 1, 2015
Last Verified:
May 1, 2015