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

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
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
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).
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
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.