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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01639209
Other study ID # REB #12-031
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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