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. 2021 Nov 11;2021(11):CD008350. doi: 10.1002/14651858.CD008350.pub3

Mulvihill 1996.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Number randomized: 20 participants total
10 participants in the PR group
10 participants in the SB group
Exclusions after randomization: none reported
Unit of analysis: individual (1 eye of each participant included)
Number analyzed: 20 participants total
10 participants in the PR group
10 participants in the SB group
Losses to follow‐up: none reported
Power calculation: not reported
Participants Country: Ireland
Age: not reported
Gender: not reported
Inclusion criteria: participants diagnosed with RRD fulfilling certain criteria:
  • single retinal break or a small group of breaks, not larger than 1 clock hour of retina in size

  • break or breaks located within the superior 8 clock hours of retina

  • absence of significant PVR

  • absence of uncontrolled glaucoma

  • person able to maintain postoperative head posturing, if required


Exclusion criteria: not reported
Equivalence of baseline characteristics: not reported
Interventions Intervention 1: PR
PR performed under local anesthesia in the operating theater in all cases. Following peribulbar anesthesia, the eye was softened using Honan's Balloon and the periorbital skin cleaned with 0.1% chlorhexidine and draped. The retinal breaks were identified, and gas then injected into the vitreous cavity 4 mm posterior to the limbus using a 30‐gauge needle. The gas used was either 0.6 mL of sulfur hexafluoride (SF6) or 0.3 mL of perfluoropropane (C3F8). Following rejection of gas, the patency of the central retinal artery was evaluated with the indirect ophthalmoscope. The retinal break was then sealed using either transconjunctival cryopexy or indirect (argon) laser. Cryopexy was used when a satisfactory reaction could not be obtained with laser. In some large bullous RDs the procedure was performed in 2 stages: the retina was allowed to flatten after gas injection and then the retinal break was sealed 1–2 days later. After gas injection, IOP was checked by applanation tonometry 3 and 6 hours later. Postoperatively the participants were instructed to posture for ≥ 16 hours per day and for ≥ 4 days so the retinal breaks were uppermost, tamponaded by the intraocular gas bubble. Topical antibiotic/steroid (betamethasone sodium phosphate plus neomycin sulfate) was administered for 4 weeks postoperatively. 
Intervention 2: SB
Conjunctiva and Tenon's capsule were opened and the subretinal fluid drained via an opening in the sclera to allow the retina to move back into position after injection of sterile air into the vitreous cavity. The retinal break was then sealed with trans‐scleral cryopexy. Finally, a hard silicone explant was sutured onto the sclera in the region of the retinal break to create a permanent scleral indentation. All SB procedures were performed under general anesthesia.
Length of follow‐up: planned: not reported; actual: mean follow‐up 16.7 months (range 5–27 months) in the PR group and 16.0 months (range 8–23 months) in the SB group
Outcomes Primary outcome: reattachment of the retina
Secondary outcomes: visual acuity, recurrence of retinal detachment, and adverse events
Intervals at which outcomes assessed: not reported
Identification Not available
Notes Type of report: published article
Funding sources: not reported
Disclosures of interest: not reported
Study period: November 1991 to February 1994
Subgroup analyses: none reported
Publication language: English
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of randomization not reported.
Allocation concealment (selection bias) Unclear risk Quote: "Participants were randomised by a closed envelope technique into one of two groups."
Masking of participants and personnel (performance bias) Unclear risk Masking of participants and personnel not reported, but surgeons could not have been masked.
Masking of outcome assessment (detection bias) Unclear risk Masking of outcome assessors not reported.
Incomplete outcome data (attrition bias)
all outcomes Low risk All participants included and randomized were analyzed.
Selective reporting (reporting bias) Unclear risk Study protocol not available.
Other bias Unclear risk Funding source not reported.