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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pneumatic retinopexy | Experimental | Patients with retinal detachment allocated to pneumatic retinopexy |
|
| Vitrectomy | Experimental | Patients with retinal detachment allocated to vitrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumatic retinopexy | Procedure |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity (ETDRS) | 12 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity (ETDRS) | 3, 6 and 24 months post intervention | |
| Visual acuity (Snellen) | 1 week, 1, 3, 6, 12 and 24 months post intervention | |
| Subjective visual function (VFQ25) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rajeev Muni, MD | Contact | 416-867-7411 | rajeev.muni@utoronto.ca | |
| Veren Juncal, MD | Contact | 416-867-7411 | verenajuncal@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rajeev Muni, FRSCS | staff | Principal Investigator |
| Verena Juncal, MD | research fellow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital Eye Clinic | Recruiting | Toronto | Ontario | M5C2T2 | Canada |
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| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| D017679 | Cryotherapy |
| D014821 | Vitrectomy |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D013812 | Therapeutics |
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| Vitrectomy |
| Procedure |
|
|
| 3, 6, 12 and 24 months post intervention |
| Anatomical success (complete retinal re-attachment with no adjuvant surgical procedure) | 3, 6, 12 and 24 months post intervention |
| Subjective health related quality of life (SF-36v2) | baseline, 1 month, 12 and 24 months post intervention |
| Aniseikonia rates | 12 and 24 months |
| Metamorphopsia rates | 3, 12 and 24 months |
| Retinal displacement rate measured with fundus autofluorescence | 3 and 12 months |
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Canada |
|
| D013508 |
| Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |