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OpenTrials
Completed

NCT Number: NCT01639209

Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment

The purpose of this research study is to compare the outcomes of pneumatic retinopexy with the outcomes of vitrectomy (with or without scleral buckle) for the management of retinal detachment, in terms of anatomical success, functional success and impact on patient quality of life.

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Key information

Conditions

Rhegmatogenous Retinal Detachment Eye Diseases Retinal Detachment Retinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, St Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

About this study

Rhegmatogenous retinal detachment (RRD)is an acute, sight threatening condition, with an incidence of approximately 10 per 100,000 population. Both of the treatments under investigation are widely used and accepted by vitreoretinal surgeons, but randomised, prospective comparison of the two techniques has not been reported in the scientific literature to date. Currently, the management decisions surrounding primary retinal detachment are grounded on a weak evidence base. The findings of this study will allow vitreoretinal surgeons and their patients to select the most appropriate intervention for that individual, in an informed and holistic manner.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients presenting with acute rhegmatogenous retinal detachment
  • Single retinal break OR group of breaks no larger than one clock hour (30°)
  • All break/s in detached retina between 8-4 o'clock
  • No significant proliferative vitreoretinopathy

Exclusion criteria

  • Inferior breaks in detached retina
  • Inability to read English language
  • Age < 18 years
  • Mental incapacity
  • Previous vitrectomy (index eye)
  • Previous retinal detachment (index eye)
  • Inability to maintain the post-operative posturing
  • Inability to carry out detailed examination of peripheral retina due to media opacity

Treatment and study plan

Vitrectomy

Procedure

Pars plana vitrectomy plus laser/cryotherapy

Pneumatic Retinopexy

Procedure

Pneumatic retinopexy plus laser/cryotherapy

Primary outcomes

  1. Visual acuity

    Time frame: 12 months post intervention

Secondary outcomes

  1. Visual acuity

    Time frame: 1 week, 1 month, 3 months and 6 months post intervention

  2. Subjective visual function

    Time frame: 3, 6 and 12 months post intervention

    Questionnaire

  3. Anatomical success (complete retinal re-attachment)

    Time frame: 3, 6 and 12 months post intervention

  4. Subjective health related quality of life

    Time frame: Baseline and 1 month post intervention

    Questionnaire

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

A Randomised Controlled Trial Comparing Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Retinal Detachment; Anatomical Success, Functional Success and Impact on Patient Quality of Life

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jul 12, 2012
Registry last updated
Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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