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

NCT06578910 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-08-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Medicontur Medical Engineering Ltd

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2024-04-25
Completion
2024-04-25

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06578910 on ClinicalTrials.gov