Tari 2009.
Study characteristics | ||
Methods | Study design: quasi‐randomised controlled trial Multicentre or single‐centre: single‐centre Setting: Tehran University Eye Research Center, Tehran, Iran Period: January 2006 to June 2007 Sample size: not reported Follow up: 11.56 months for non‐integrated group and 13.16 months for integrated group |
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Participants | 100 patients. Mean age: 42.32 years for evisceration group and 39.56 years for enucleation group Sex: 15 women and 35 men for evisceration group; and 9 women and 41 men for evaluation group Inclusion criteria: not reported Exclusion criteria: significant preoperative motility abnormalities, cases of severe phthisis, and cases that were not followed up for at least 4 months |
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Interventions | Enucleation with HA (integrated group) (n = 50) versus evisceration plus quadrisection of sclera with alloplastic implantation (non‐integrated group) (n = 50) There was no peg device. Enucleation via the traditional technique and evisceration plus scleral quadrisection |
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Outcomes | The primary outcome was the presence or absence of exposure or extrusion and deep superior sulcus deformity, and the secondary outcome was implant motility measured by detecting the amount of overlying conjunctival movement. | |
Notes | Reasons for surgery were: painful blinded eye, cosmetic unacceptability, acute trauma, and endophthalmitis. The reason for the surgery was the same for both groups. However, all the trauma patients had enucleation and all the endophthalmitis patients had evisceration. There was no financial support. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Participants were randomly divided in 2 groups for alternate surgical plans including enucleation with HA implantation or evisceration plus quadrisection of sclera with alloplastic implantation. |
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 | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed the study. |
Selective reporting (reporting bias) | Low risk | No evidence |
Other bias | Low risk | No evidence. The authors declare no financial support or relationships that may pose a conflict of interest. |
HA: hydroxyapatite; PMMA: polymethylmethacrylate; PP: porous polyethylene.