Comparison of Postoperative Aqueous Flare After 20G Versus 23G Pars Plana Vitrectomy

Macular Hole Clinical Trial

— 20Gvs23G  

Official title:

Comparison of Postoperative Aqueous Flare After 20G Versus 23G Pars Plana Vitrectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01969929
• Other study ID #: UKK-13-247
• Secondary ID: 13-247
• Status: Active, not recruiting
• Phase: N/A
• First received: October 18, 2013
• Last updated: May 29, 2015
• Start date: October 2013
• Est. completion date: October 2015

Study information

• Verified date: May 2015
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

To compare postoperative inflammation and breakdown of blood-retinal barrier as measured by a laser flare-cell meter in 20G versus 23G vitrectomy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Epiretinal Membrane
• Macular Hole
• Macular Pucker

Intervention

Procedure:
• 20G Vitrectomy

• 23G vitrectomy

Locations

Country	Name	City	State
Germany	Center of Ophthalmology, University of Cologne	Cologne	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction		3 weeks	No
Primary	Alteration of aqueous flare between preoperative and 3-week-postoperative time point		3 weeks	No
Secondary	Visual acuity change		3 weeks	No
Secondary	Closure of Macular hole		3 weeks	No