Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment in Patients With Extended Criteria

August 21, 2019 updated by: Unity Health Toronto

A Randomized Controlled Trial Comparing Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Retinal Detachment in Patients With Extended Criteria; Anatomical Success, Functional Success and Impact on Patient Quality of Life

Objective: To compare outcomes of retinal detachment repair following pneumatic retinopexy (PnR) versus pars plana vitrectomy in terms of anatomical success, functional success and patient quality of life in patients with extended criteria.

Methods: A prospective, randomized, controlled trial will be conducted with 178 patients presenting at St. Michael's Hospital with primary retinal detachment (RD). Inclusion criteria include: a single or multiple retinal tears in detached retina between 7 and 5 o'clock being of any size and any distance apart from each other, including giant retinal tears with inferior aspect above 5 and 7 o'clock, RD with no identifiable tear but where suspected tear is between 7 and 5 o'clock, retinoschisis with RD if tears are located between 7 and 5 o'clock, mild proliferative vitreoretinopathy, none or mild vitreous hemorrhage. Patients will be excluded if there is a small retinal tear or multiple tears less than 30o apart between 8 and 4 o'clock in detached retina, retinal tear in detached retina between 5 and 7 o'clock, <18 years old, inability to read English, mental incapacity, previous history of RD, scleral buckle or vitrectomy in index eye, inability to maintain appropriate head posture at post-operative period and inability to visualize peripheral retinal due to media opacity. Patients will be randomly allocated into two groups: PnR + cryotherapy/laser or vitrectomy + cryotherapy/laser and the intervention will take place within 24 hours and 72 hours for attached and detached macula status, respectively. Patients will undergo a complete ophthalmological examination, including visual acuity and fundus assessment at baseline and at 3, 6 and 12 months after surgery. Visual acuity will also be measured at 1, 7 and 30 days after surgery. Global health related quality of life will be evaluated with the SF-36v2 questionnaire at baseline, 1 month, 1 and 2 years after intervention, while the VFG25 questionnaire will be applied at 3, 6, 12 and 24 months after surgery to measure vision related quality of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
      • Toronto, Canada
        • Recruiting
        • Sunnybrook Health Sciences Centre
    • Ontario
      • Toronto, Ontario, Canada, M5C2T2
        • Recruiting
        • St. Michael's Hospital Eye Clinic
        • Contact:
          • Phillip To
          • Phone Number: 4168677411
          • Email: top@smh.ca
        • Contact:
          • Rajeev Muni, MD Msc FRCSC
          • Phone Number: 4168677411

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Single retinal tear or group of tears (any distance apart) in detached retina located between 7 and 5 o'clock.
  • Retinal detachment with no identifiable tear but where suspected tear is located between 7-5 o'clock based on Lincoff rules
  • Any size of retinal tear, including giant retinal tears, if the inferior aspect of it is above 5 and 7 o'clock
  • Retinoschisis with retinal detachment if tears are located between 7 and 5 o'clock
  • There may be mild proliferative vitreoretinopathy (unless there is a visible traction on the break)
  • None or mild vitreous hemorrhage. Note: vitreous hemorrhage will be considered mild if it does not impair an adequate examination of the retinal periphery.
  • In the opinion of the investigator, PnR is likely to achieve anatomical re-attachment of the retina

Exclusion Criteria:

  • Group of tears <30o apart in detached retina if all located within 8-4 o'clock
  • Single retinal tear smaller than 1 o'clock in detached retina between 8-4 o'clock
  • Retinal tears below the 5 and 7 o'clock meridian in detached retina (note that additional tears in attached retina are acceptable)
  • Inability to read English language
  • Age <18 years
  • Mental incapacity
  • Previous vitrectomy or scleral buckle (index eye)
  • Previous retinal detachment (index eye)
  • Inability to maintain the strict post-operative posturing requirements of pneumatic retinopexy
  • Inability to carry out detailed examination of the peripheral retina due to media opacity NOTE: Lens/posterior hyaloid status does not affect eligibility.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pneumatic retinopexy
Patients with retinal detachment allocated to pneumatic retinopexy
Procedure: Pneumatic retinopexy
Other Names:
  • Pneumatic retinopexy plus laser/cryotherapy
Experimental: Vitrectomy
Patients with retinal detachment allocated to vitrectomy
Procedure: Vitrectomy
Other Names:
  • Pars plana vitrectomy plus laser/cryotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity (ETDRS)
Time Frame: 12 months post intervention
12 months post intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual acuity (ETDRS)
Time Frame: 3, 6 and 24 months post intervention
3, 6 and 24 months post intervention
Visual acuity (Snellen)
Time Frame: 1 week, 1, 3, 6, 12 and 24 months post intervention
1 week, 1, 3, 6, 12 and 24 months post intervention
Subjective visual function (VFQ25)
Time Frame: 3, 6, 12 and 24 months post intervention
3, 6, 12 and 24 months post intervention
Anatomical success (complete retinal re-attachment with no adjuvant surgical procedure)
Time Frame: 3, 6, 12 and 24 months post intervention
3, 6, 12 and 24 months post intervention
Subjective health related quality of life (SF-36v2)
Time Frame: baseline, 1 month, 12 and 24 months post intervention
baseline, 1 month, 12 and 24 months post intervention
Aniseikonia rates
Time Frame: 12 and 24 months
12 and 24 months
Metamorphopsia rates
Time Frame: 3, 12 and 24 months
3, 12 and 24 months
Retinal displacement rate measured with fundus autofluorescence
Time Frame: 3 and 12 months
3 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Investigators

  • Principal Investigator: Rajeev Muni, FRSCS, Staff
  • Principal Investigator: Verena Juncal, MD, Research Fellow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 18, 2016

Study Record Updates

Last Update Posted (Actual)

August 26, 2019

Last Update Submitted That Met QC Criteria

August 21, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Extended criteria pneumaticPPV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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