Table 2.
Characteristics of included studies [ordered by study ID]
| Mulvihill 1996 | ||
| Methods |
Study design: parallel group randomized controlled trial Number randomized: 20 participants total 10 participants in the pneumatic retinopexy group 10 participants in the scleral buckle 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 pneumatic retinopexy group 10 participants in the scleral buckle 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 rhegmatogenous retinal detachment fulfilling certain criteria:
|
|
| Interventions |
Intervention 1: pneumatic retinopexy Intervention 2: scleral buckle “Pneumatic retinopexy was performed under local anaesthesia in the operating theatre in all cases. Following peribulbar anaesthesia, the eye was softened using Honan’s Balloon and the periorbital skin cleaned with 0.1% chlorhexidine and then 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 sulphur 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 two stages: the retina was allowed to flatten after gas injection and then the retinal break was sealed one to two days later. After gas injection the intraocular pressure was checked by applanation tonometry three and six hours later. Postoperatively the participants were instructed to posture for at least sixteen hours per day and for at least four days so the retinal breaks were uppermost, tamponaded by the intraocular gas bubble. Topical antibiotic/steroid (Betnesol-N) was administered for four weeks postoperatively. Briefly, scleral buckle was performed as follows. The 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 of the scleral buckle procedures were carried-out under general anaesthesia.” Length of follow-up: Planned: not reported Actual: average follow-up 16.7 months (range 5 to 27 months) in the pneumatic retinopexy group and 16.0 months (range 8 to 23 months) in the scleral buckle 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 |
|
| 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 | “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. |
| Tornambe 1989 | ||
| Methods |
Study design: parallel group randomized controlled trial Number randomized: 200 eyes of 198 participants total; number not reported by treatment group Exclusions after randomization: none reported Unit of analysis: individual (1 eye of each participant included, except for 2 participants for which both eyes were included) Number analyzed: 198 eyes of 196 participants total; 103 eyes in the pneumatic retinopexy group (41 eyes with macular-attached; 62 eyes with macular-detached) 95 eyes in the scleral buckle group (35 eyes with macular-attached; 60 eyes with macular-detached) Losses to follow-up: 2 eyes of 2 participants; 1 participant died of a myocardial infarction 2 months after scleral buckle and 1 was lost to follow-up Power calculation: not reported |
|
| Participants |
Country: United States Age: not reported Gender: 64/103 (62%) men and 39/103 (38%) women in pneumatic retinopexy group; 65/95 (68%) men and 30/95 (32%) women in scleral buckle group Inclusion criteria:
Exclusion criteria:
|
|
| Interventions |
Intervention 1: pneumatic retinopexy Intervention 2: scleral buckle “When pneumatic retinopexy was used, the surgeon recorded the type and volume of gas injected (the type of gas selected was not randomized), the number of cryopexy or laser photocoagulation applications, the incidence and duration of central retinal artery closure, paracentesis, intraocular pressures at 5, 10, 20, 30 and 60 minutes after gas introduction, and all intraoperative complications. When scleral buckle was used, the surgeon recorded the type of buckle material, the number of cryopexy applications, drainage of subretinal fluid, the incidence and duration of central retinal artery closure, paracentesis, the type and volume of gas injected, and all intraoperative complications.” Length of follow-up: Planned: not reported Actual: 24 months |
|
| Outcomes | Primary and secondary outcomes not specified Outcome, as define d: surgical success (retinal reattachment at 6 months after 1 surgical intervention), visual acuity, recurrence of retinal detachment, morbidity, and adverse events Intervals at which outcomes assessed: surgical success (6, 12, and 24 months), visual acuity (1, 6, 12, and 24 months), and adverse events (1, 3, 7, and 14 days; 1, 2, 4, and 6 months) |
|
| Notes |
Type of report(s): published articles and conference abstract Funding sources: not reported Disclosures of interest: not reported Study period: not reported Subgroup analyses: macular-attached and macular-detached (participants stratified before being randomized for treatment) Publication language: English |
|
| Risk of bias | ||
| Bias | Authors’ judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of randomization not reported; however, “A separate randomization schedule was prepared for each center.” |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment before randomization not reported. |
| 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 personnel assessing retinal reattachment not reported; “Visual acuity was evaluated by an examiner, in a masked manner, who was unacquainted with the case.” |
| Incomplete outcome data (attrition bias) All outcomes |
Low risk | 2 eyes (2 participants) of 198 eyes excluded from the analysis |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not available. |
| Other bias | Unclear risk | Funding source not reported. |
DD: disc diameter
ETDRS: Early Treatment Diabetic Retinopathy Study
RD: retinal detachment