NCT07288086

Reliability and Effectiveness of New Enova Preloaded Intaocular Lens and Cartridge System

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Istanbul University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the safety and efficacy of the new Enova® preloaded monofocal intraocular lens and cartridge injector system in cataract surgery

Detailed description

In this prospective and single-center clinical study, the safety and efficacy of the Enova PGF3 intraocular lens (IOL) and cartridge injector system will be evaluated. The Enova PGF3 cartridge injector system is designed to be used in cataract surgeries. Cataract patients aged 40 years and older, both male and female, without any serious ocular disease other than cataracts, will undergo IOL implantation following cataract surgery. It is planned to perform a total of 200 implantations with either unilateral or bilateral implantation of the participants' eyes. Postoperative visual acuity, refraction, patient satisfaction, and adverse events will be monitored during follow-up visits at day 1, week 1, and month 1. The primary objectives of the study are to achieve an uncorrected distance visual acuity of 20/20 or better, and to maintain an error and complication rate related to the preloaded system below 7.5%. Secondary objectives include evaluating patient satisfaction and assessing whether surgeons find the preloaded system easy to use and if it meets their expectations. The primary endpoints are refractive stability within ±0.50 D, uncorrected distance visual acuity of 20/20 or better, and a general clinical performance rating of the preloaded system with a score of 95% or higher. Secondary endpoints include the duration of surgery, accuracy of lens positioning, surgical complications, surgeon-reported ease of use, and patient satisfaction survey results meeting expectations. As a safety parameter, adverse events reported in postoperative surgical reports will be evaluated.

Conditions

• Cataract Surgery
• Intraocular Lens

Interventions

Type	Name	Description
DEVICE	Preloaded intraocular lens system	This intervention uses a preloaded IOL delivery system, which allows for a single-use, sterile implantation during standard phacoemulsification cataract surgery. Unlike standard manually loaded IOLs, this system reduces preparation time and minimizes handling of the lens, potentially improving surgical efficiency and maintaining lens sterility.

Timeline

• Start date: 2025-05-10
• Primary completion: 2026-06-15
• Completion: 2026-07-11
• First posted: 2025-12-17
• Last updated: 2026-03-24

Locations

1 site across 1 country: Turkey (Türkiye)