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

NCT ID: NCT01969929

Last Updated: 2015-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-10-31

Brief Summary

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

Detailed Description

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Conditions

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Macular Hole Macular Pucker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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20G

20G vitrectomy with scleral and conjunctival sutures for closure

Group Type ACTIVE_COMPARATOR

20G Vitrectomy

Intervention Type PROCEDURE

23G

23G transconjunctival sutureless vitrectomy

Group Type ACTIVE_COMPARATOR

23G vitrectomy

Intervention Type PROCEDURE

Interventions

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20G Vitrectomy

Intervention Type PROCEDURE

23G vitrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Sascha Fauser

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center of Ophthalmology, University of Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 30448886 (View on PubMed)

Other Identifiers

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13-247

Identifier Type: OTHER

Identifier Source: secondary_id

UKK-13-247

Identifier Type: -

Identifier Source: org_study_id

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