Colen 2000.
Study characteristics | ||
Methods | Study design: randomised controlled trial Multicentre or single‐centre: multicentre (two centres) Setting: the Rotterdam Eye Hospital, Rotterdam, and in the University Medical Center, Utrecht, Netherlands Period: February 1997 to May 1999 Sample size: a difference of 0.10 or more between the two types of implants would be clinically relevant Follow up: 3 months |
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Participants | 34 patients eligible for the study; 30 ana lysed Mean age: 64.0 years for hydroxyapatite group and 57.8 years for acrylic group Sex: 7 men and 7 women for hydroxyapatite group; 9 men and 7 women in acrylic group Inclusion criteria: patients with intraocular melanoma, without extrascleral extension on ultrasound examination Exclusion criteria: patients with a visual acuity of less than 6/12 (20/40) in the remaining eye and patients with a history of abnormal eye motility, strabismus, any eye surgery, and chronic inflammatory ocular or orbital disorders |
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Interventions | Hydroxiapatite (integrated group) (n = 14) versus acrylic (non‐integrated group) (n = 16) There was no peg device. All participants underwent the enucleation technique (scleral‐covered spherical orbital implant). |
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Outcomes | Motility; saccadic gain (i.e. dividing the saccadic amplitude by the target amplitude) and saccadic symmetry (i.e. artificial eye amplitude divided by health eye amplitude) | |
Notes | 21 healthy volunteers served as control participants. The reason for surgery was intraocular melanoma. This study was supported by Rotterdam Eye Hospital Research Fund, Rotterdam, Netherlands |
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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) | Low risk | Selection by opening an envelope with a previously randomised |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were unaware of the type of enucleation implant. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The investigators who recorded the eye movements were unaware of the type of enucleation implant. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 11.77% dropouts |
Selective reporting (reporting bias) | Low risk | No evidence |
Other bias | Unclear risk | No evidence; no report of conflict of interest. |