This trial is active, not recruiting.

Conditions macular hole, macular pucker
Treatments 20g vitrectomy, 23g vitrectomy
Sponsor University of Cologne
Start date October 2013
End date October 2015
Trial size 100 participants
Trial identifier NCT01969929, 13-247, UKK-13-247


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose basic science
(Active Comparator)
20G vitrectomy with scleral and conjunctival sutures for closure
20g vitrectomy
(Active Comparator)
23G transconjunctival sutureless vitrectomy
23g vitrectomy

Primary Outcomes

Alteration of aqueous flare between preoperative and 3-week-postoperative time point
time frame: 3 weeks

Secondary Outcomes

Visual acuity change
time frame: 3 weeks
Closure of Macular hole
time frame: 3 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Comparison of Postoperative Aqueous Flare After 20G Versus 23G Pars Plana Vitrectomy
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Cologne.