NCT01969929

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 25, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

October 18, 2013

Last Update Submit

May 29, 2015

Conditions

Macular HoleMacular Pucker

Outcome Measures

Primary Outcomes (1)

  • Alteration of aqueous flare between preoperative and 3-week-postoperative time point

    3 weeks

Secondary Outcomes (2)

  • Visual acuity change

    3 weeks

  • Closure of Macular hole

    3 weeks

Other Outcomes (1)

  • Patient satisfaction

    3 weeks

Study Arms (2)

20G

ACTIVE COMPARATOR

20G vitrectomy with scleral and conjunctival sutures for closure

Procedure: 20G Vitrectomy

23G

ACTIVE COMPARATOR

23G transconjunctival sutureless vitrectomy

Procedure: 23G vitrectomy

Interventions

20G VitrectomyPROCEDURE
20G
23G vitrectomyPROCEDURE
23G

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years macular hole macular pucker willing to perform follow up written signed consent

You may not qualify if:

  • other relevant eye disease: retinal detachment, provect cataract, diabetic retinopathy, AMD, relevant glaucoma, pre-surgery except for cataract surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Ophthalmology, University of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30448886DERIVED

MeSH Terms

Conditions

Retinal PerforationsEpiretinal Membrane

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 18, 2013

First Posted

October 25, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

June 1, 2015

Record last verified: 2015-05

Locations

DE(1)