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

Rhegmatogenous Retinal Detachment Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Retinal Detachment in Patients With Extended Criteria; Anatomical Success, Functional Success and Impact on Patient Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02871531
• Other study ID #: Extended criteria pneumaticPPV
• Status: Recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: November 2023

Study information

• Verified date: August 2019
• Source: St. Michael's Hospital, Toronto
• Contact: Rajeev Muni, MD
• Phone: 416-867-7411
• Email: rajeev.muni[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: November 2023
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment
• Rhegmatogenous Retinal Detachment

Intervention

Procedure:
• Pneumatic retinopexy

• Vitrectomy

Locations

Country	Name	City	State
Canada	St. Michael's Hospital Eye Clinic	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto

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 (ETDRS)		12 months post intervention
Secondary	Visual acuity (ETDRS)		3, 6 and 24 months post intervention
Secondary	Visual acuity (Snellen)		1 week, 1, 3, 6, 12 and 24 months post intervention
Secondary	Subjective visual function (VFQ25)		3, 6, 12 and 24 months post intervention
Secondary	Anatomical success (complete retinal re-attachment with no adjuvant surgical procedure)		3, 6, 12 and 24 months post intervention
Secondary	Subjective health related quality of life (SF-36v2)		baseline, 1 month, 12 and 24 months post intervention
Secondary	Aniseikonia rates		12 and 24 months
Secondary	Metamorphopsia rates		3, 12 and 24 months
Secondary	Retinal displacement rate measured with fundus autofluorescence		3 and 12 months