Experience Using a New High-Density Polyethylene-Based Porous Orbital Implant: Explorative 1-Year Performance and Safety Results

OBJECTIVES: To describe our experience with a new high-density porous polyethylene orbital implant post-enucleation and evisceration and comment on their performance and safety. METHODS: Patients with an indication of enucleation or evisceration with orbital implantation were included in a prospective study. All patients were implanted with OCULFIT orbital implants (AJL Ophthalmic S.A.) and followed up over 12 months. Anatomical and functional parameters, motility, and aesthetic appearance were evaluated. Patient satisfaction on a scale of 0 (very bad) to 5 (excellent), complications and success rates were reported. RESULTS: Overall, 16 enucleated and 17 eviscerated eyes were analyzed. Orbital implant motility was good for 93.8% and 100% of enucleated and eviscerated patients, respectively. No shortened fornixes were found after external prosthesis placement, and palpebral fissure, orbital volume, and lower eyelid laxity were symmetric with the contralateral eye for the vast majority. The aesthetic appearance was good for 87.5% and 100% of enucleated and eviscerated patients at the last visit with no differences between groups. Excellent satisfaction was reported for 100% and 94.1% of enucleated and eviscerated patients. Anatomical and functional success rates were 78.8% and 81.8%, respectively. No exposure, infection or complications related to surgery were reported during the follow-up. CONCLUSIONS: After 1 year of follow-up, OCULFIT orbital implants provide excellent patient satisfaction and performance in terms of motility and symmetry with the contralateral eye after external prosthesis placement with no complications related to the surgical procedure. No differences between enucleated and eviscerated eyes were found, and aesthetic results were remarkable for both groups. Conclusions should be interpreted with caution due to the small sample size.