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

NCT ID: NCT02871531

Last Updated: 2019-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2023-11-30

Brief Summary

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.

Conditions

Rhegmatogenous Retinal Detachment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pneumatic retinopexy

Patients with retinal detachment allocated to pneumatic retinopexy

Group Type: EXPERIMENTAL

Pneumatic retinopexy

Intervention Type: PROCEDURE

Vitrectomy

Patients with retinal detachment allocated to vitrectomy

Group Type: EXPERIMENTAL

Vitrectomy

Intervention Type: PROCEDURE

Interventions

Pneumatic retinopexy

Intervention Type: PROCEDURE

Vitrectomy

Intervention Type: PROCEDURE

Other Intervention Names

Pneumatic retinopexy plus laser/cryotherapy; Pars plana vitrectomy plus laser/cryotherapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rajeev Muni, FRSCS

Role: PRINCIPAL_INVESTIGATOR

staff

Verena Juncal, MD

Role: PRINCIPAL_INVESTIGATOR

research fellow

Locations

St. Michael's Hospital Eye Clinic

Toronto, Ontario, Canada

Site Status: RECRUITING

Sunnybrook Health Sciences Centre

Toronto, , Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Rajeev Muni, MD

Role: CONTACT

rajeev.muni@utoronto.ca

416-867-7411

Veren Juncal, MD

Role: CONTACT

verenajuncal@gmail.com

416-867-7411

Facility Contacts

Rajeev Muni, MD Msc FRCSC

Role: primary

4168677411

Phillip To

Role: backup

top@smh.ca

4168677411

Peter Kertes

Role: primary

Other Identifiers

Extended criteria pneumaticPPV

Identifier Type: -

Identifier Source: org_study_id