NCT06578923

Retrospective, Non-interventional, Comparative Clinical Investigation of the Safety and Performance of 690AD and 690ADY Monofocal Intraocular Lens Implantation With Extended Patient Enrolment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: Medicontur Medical Engineering Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOLs) are 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 690AD or 690ADY IOLs mono- or binocularly between June 2022 - September 2023. Data from five visits will be collected: * Baseline preoperative (maximum 90 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
• Intraocular Lens Complication
• Intraocular Lens Opacification

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.
BEHAVIORAL	Patient satisfaction questionnare	VFQ- 25 (Visual Function Questionnare) to be completed during 12 month visit.

Timeline

• Start date: 2024-01-15
• Primary completion: 2024-05-03
• Completion: 2024-05-03
• First posted: 2024-08-30
• Last updated: 2024-08-30

Locations

2 sites across 1 country: Hungary