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

  • STATUS
    Recruiting
  • End date
    Nov 23, 2023
  • participants needed
    178
  • sponsor
    St. Michael's Hospital, Toronto
Updated on 23 January 2021

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.

Details
Condition Rhegmatogenous Retinal Detachment
Treatment Vitrectomy, Pneumatic Retinopexy
Clinical Study IdentifierNCT02871531
SponsorSt. Michael's Hospital, Toronto
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Rhegmatogenous Retinal Detachment??
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
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