A comparative assessment of ocular prostheses motility in patients with atrophia bulbi versus implanted anophthalmic sockets: A randomized controlled trial

Purpose This randomized controlled trial aimed to compare the motility and patient satisfaction of prefabricated versus custom‐made ocular prostheses in patients with atrophia bulbi and implanted anophthalmic sockets. Materials and Methods This randomized controlled trial enrolled 48 patients, 8 of whom withdrew from the trial upon follow‐up. Thus, this study was conducted on 40 patients ( N = 40) (aged 41.6 ± 20.3 years) with a unilateral ocular defect: 20 with implanted anophthalmic sockets and 20 with atrophia bulbi. Patients of either type were randomly allocated based on the type of ocular prostheses into a study group, either receiving a custom‐made ocular prosthesis or the control group, receiving a prefabricated ocular prosthesis. Motility of the ocular prostheses, the primary outcome, was examined in the four groups ( n = 10): implanted anophthalmic prefabricated (IA‐PF), implanted anophthalmic custom‐made (IA‐CM), atrophia bulbi prefabricated (AB‐PF), and atrophia bulbi custom‐made (AB‐CM). A validated satisfaction questionnaire with appearance and motility of ocular prosthesis was given to all patients at the time of prosthesis insertion, and then 3 months later. Comparisons between groups were conducted using Welch's ANOVA with effect sizes expressed as eta‐squared ( η 2 ). Within the same group, paired samples t ‐test was used, and corresponding effect sizes were reported as Cohen's d . All statistical tests were 2‐tailed ( α = 0.05). Results At the prosthesis insertion appointment, the total movement differed significantly among the four groups. Welch's ANOVA showed a strong group effect ( F ( w )(df = 3, 18.88) = 49.30) ( p < 0.001), with a large effect size ( η 2 = 0.76, 95% confidence interval [CI] = 0.57–0.82). After 3 months, the group differences remained highly significant ( F ( w )(df = 3, 17.08) = 113.97) ( p < 0.001), with a large effect size ( η 2 = 0.83, 95% CI = 0.69–0.88). At insertion, motility satisfaction was significantly lower in the IA‐PF group versus both IA‐CM and AB‐CM groups, and lower in the AB‐PF group versus AB‐CM group. At 3 months, all pairwise comparisons were significant after Bonferroni correction, with IA‐PF group consistently the lowest and AB‐CM group the highest. Conclusions Ocular prostheses in patients with atrophia bulbi present higher overall motility and patient satisfaction than those with implanted anophthalmic sockets. Patient satisfaction with appearance is not affected by the type of prosthesis or ocular defect. However, patient satisfaction with motility is enhanced with custom‐made ocular prostheses.