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Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment

U

Unity Health Toronto

Status

Completed

Conditions

Rhegmatogenous Retinal Detachment

Treatments

Procedure: Vitrectomy
Procedure: Pneumatic retinopexy

Study type

Interventional

Funder types

Other

Identifiers

NCT01639209
REB #12-031

Details and patient eligibility

About

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.

Full description

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.

Enrollment

176 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

176 participants in 2 patient groups

Vitrectomy
Experimental group
Treatment:
Procedure: Vitrectomy
Pneumatic retinopexy
Experimental group
Treatment:
Procedure: Pneumatic retinopexy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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