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

NCT02871531 | Unknown

• 1 other identifier: Extended criteria pneumaticPPV
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 2

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

Keywords

retinal detachment; pneumatic retinopexy; vitrectomy

Outcome Measures

Primary Outcomes (1)

• Visual acuity (ETDRS)

  12 months post intervention

Secondary Outcomes (8)

• 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)

  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

Study Arms (2)

Pneumatic retinopexy

EXPERIMENTAL

Patients with retinal detachment allocated to pneumatic retinopexy

Procedure: Pneumatic retinopexy

Vitrectomy

EXPERIMENTAL

Patients with retinal detachment allocated to vitrectomy

Procedure: Vitrectomy

Interventions

Pneumatic retinopexy PROCEDURE

Also known as: Pneumatic retinopexy plus laser/cryotherapy

Pneumatic retinopexy

Vitrectomy PROCEDURE

Also known as: Pars plana vitrectomy plus laser/cryotherapy

Vitrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (2)

St. Michael's Hospital Eye Clinic

Toronto, Ontario, M5C2T2, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Canada

RECRUITING

MeSH Terms

Conditions

Retinal Detachment

Interventions

Lasers; Cryotherapy; Vitrectomy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Therapeutics; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Rajeev Muni, FRSCS

  staff

  PRINCIPAL INVESTIGATOR

• Verena Juncal, MD

  research fellow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajeev Muni, MD

CONTACT

416-867-7411; rajeev.muni@utoronto.ca

Veren Juncal, MD

CONTACT

416-867-7411; verenajuncal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 18, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2023
• Last Updated: August 26, 2019

Record last verified: 2019-08

Locations

CA (2)