NCT06578910

Retrospective, Non-interventional Clinical Investigation of the Safety and Performance of 640AD Monofocal Intraocular Lens

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Medicontur Medical Engineering Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOL) is indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), secondarily to removal of the crystalline lens. The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power. The study will be performed partially as a retrospective study with patients enrolled who had been implanted with 640AD IOLs mono- or binocularly between December 2021 - December 2022. Data from five visits will be collected: * Baseline preoperative (maximum 30 days prior to surgery)- retrospective * IOL implantation Day 0 - retrospective * Postoperative visit at Day 1 (+/- 0 days) - retrospective * Postoperative visit at 1 month (+/- 2 weeks) - retrospective * Postoperative visit at 12 months (+/- 3 months) - consent and prospective visit

Conditions

• Cataract
• Pseudophakia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Standard of care	12 months after the IOL implantation: measurement of intraocular pressure, slitlamp and fundus examination, visual acuity, manifest refraction.
OTHER	Patient satisfaction questionnare	VFQ- 25 (Visual Function Questionnare) to be completed during 12 month visit.

Timeline

• Start date: 2023-05-23
• Primary completion: 2024-04-25
• Completion: 2024-04-25
• First posted: 2024-08-30
• Last updated: 2024-08-30

Locations

1 site across 1 country: Hungary