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. 2016 Nov 7;2016(11):CD010293. doi: 10.1002/14651858.CD010293.pub2

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.
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
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.
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.
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.