Rhegmatogenous Retinal Detachment
Conditions
Keywords
Retinal detachment, Pneumatic retinopexy, Vitrectomy
Brief 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.
Detailed 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.
Interventions
PROCEDUREVitrectomy
Pars plana vitrectomy plus laser/cryotherapy
PROCEDUREPneumatic retinopexy
Pneumatic retinopexy plus laser/cryotherapy
Sponsors
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity | 12 months post intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | 1 week, 1 month, 3 months and 6 months post intervention | — |
| Subjective visual function | 3, 6 and 12 months post intervention | Questionnaire |
| Anatomical success (complete retinal re-attachment) | 3, 6 and 12 months post intervention | — |
| Subjective health related quality of life | Baseline and 1 month post intervention | Questionnaire |
Countries
Canada
Outcome results
None listed