Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment

Rhegmatogenous Retinal Detachment Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639209
• Other study ID #: REB #12-031
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: May 2017

Study information

• Verified date: September 2019
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment
• Rhegmatogenous Retinal Detachment

Intervention

Procedure:
• Vitrectomy
Pars plana vitrectomy plus laser/cryotherapy
• Pneumatic retinopexy
Pneumatic retinopexy plus laser/cryotherapy

Locations

Country	Name	City	State
Canada	Department of Ophthalmology, St Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity		12 months post intervention
Secondary	Visual acuity		1 week, 1 month, 3 months and 6 months post intervention
Secondary	Subjective visual function	Questionnaire	3, 6 and 12 months post intervention
Secondary	Anatomical success (complete retinal re-attachment)		3, 6 and 12 months post intervention
Secondary	Subjective health related quality of life	Questionnaire	Baseline and 1 month post intervention