Shome 2010.
Study characteristics | ||
Methods | Study design: randomised controlled trial Multicentre or single‐centre: not reported Setting: Hyderabad, India Period: July 2004 to June 2007 Sample size: to ascertain a 30% difference with 80% power and 5% error in between the 3 groups, inclusion of a minimum of 39 patients in each group was necessary. Follow up: mean follow‐up in months per group: PMMA traditional, 16.4; PMMA myoconjunctival, 17.3 and; porous polyethylene, 15.6. |
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Participants | 150 participants Mean age: not reported Sex: not reported Inclusion criteria: not reported Exclusion criteria: participants who had undergone prior radiotherapy and periocular chemotherapy |
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Interventions | Integrated porous polyethylene (PP) (integrated group) (n = 50) versus PMMA traditional (non‐integrated group) (n = 50) versus PMMA myoconjunctival (non‐integrated group) (n = 50) There was no peg device. All patients underwent enucleation technique. In the PP group, the enucleation was performed using the scleral cap technique. In the PMMA traditional group, the enucleation was done with muscle imbrication. In the PMMA myoconjunctival group, the enucleation was done with myoconjunctival technique, which is an alternative to muscle imbrication. |
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Outcomes | The primary outcome measured was to compare and evaluate implant and prosthesis movement among these 3 groups of patients. The secondary outcomes were implant displacement and exposure. | |
Notes | There was no report of the reasons for surgery. This study was supported by Hyderabad Eye Institute, Hyderabad, India. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Masked observer |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported |
Selective reporting (reporting bias) | Low risk | No evidence |
Other bias | Low risk | No evidence. There was no proprietary or commercial interest in any materials discussed in this article. |