NCT01716507

Brief Summary

This study is a comparison (23 gauge vs 20 gauge instrumentation) of surgical instrumentation for retinal detachment repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2012

Completed
Last Updated

December 12, 2016

Status Verified

December 1, 2016

Enrollment Period

3.2 years

First QC Date

October 25, 2012

Last Update Submit

December 9, 2016

Conditions

Retinal Detachment

Keywords

RRDRhegmatogenousRetinalDetachmentPPVPars Plana VitrectomyGauge

Outcome Measures

Primary Outcomes (1)

  • Assess the initial retinal reattachment rates by comparing the percentages/amount.

    1 Year

Secondary Outcomes (3)

  • Change in best-corrected visual acuity by comparing letters read.

    6 months

  • Reattachment rates with 23 gauge and 20 gauge PPV by comparing the amount.

    1 year

  • Operating time for 23 gauge versus 20 gauge PPV (time measurement)

    1 day- Day of surgery

Other Outcomes (1)

  • Compare rates of intraoperative and postoperative complications by comparing the amount and severity of these complications.

    1 year

Study Arms (2)

20 gauge pars plana vitrectomy

OTHER

20 gauge pars plana vitrectomy for retinal detachment repair

Procedure: Retinal Detachment repair

23 gauge pars plana vitrectomy

OTHER

23 gauge pars plana vitrectomy for retinal detachment repair

Procedure: Retinal Detachment repair

Interventions

Retinal Detachment repairPROCEDURE

Comparing 23 gauge vs 20 gauge pars plana vitrectomy.

20 gauge pars plana vitrectomy23 gauge pars plana vitrectomy

Eligibility Criteria

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

You may qualify if:

  • Ability to provide written consent and comply with study assessments for the full duration of the study.
  • Presence of retinal detachment with history of cataract surgery.
  • Vision of hand motion or better.

You may not qualify if:

  • Presence of a very large tear or type of retinal detachment usually a result of trauma.
  • Prior eye surgery except for cataract surgery.
  • Presence of significant scar tissue.
  • Presence of retinal detachment due to hole in the macula.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Jason Hsu, MD

    Wills Eye

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2012

First Posted

October 29, 2012

Study Start

April 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

December 12, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)