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Comparative Analysis of the Visual Performance and Patient Satisfaction After Cataract Surgery With Implantation of a Medicontur Monofocal (877PAY) or a Medicontur Extended Depth of Focus (877PEY) IOL

NCT06642779•Medicontur Medical Engineering Ltd

Summary

The purpose of this multi-center, prospective, randomized, comparative clinical investigation was to evaluate and compare the visual performance at far, intermediate and near distances, the presence of photopic phenomena and patient satisfaction after cataract surgery in patients implanted binocularly with a Medicontur monofocal (877PAY) or a Medicontur extended depth of focus (877PEY) IOL models. The visit schedule included a total of 6 visits, in addition to the IOL implantation surgery, with the listed follow-up timeline: * screening and baseline assessments * day 0 (IOL implantation surgery) * day 1 * month 1 * month 3 * month 6 * month 12

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•cataractous patients who wish to be partly spectacle independent
•cataractous lens changes as demonstrated by best corrected visual acuity of 20/40 or worse either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract-related visual symptoms\*
•best corrected visual acuity to be better than 20/25 (0.1 logMAR) after cataract removal and IOL implantation\*
•≤ 1.0 D of preoperative keratometric astigmatism;
•clear intraocular media other than cataract;
•given written informed consent by subject;
•subjects are willing and able to comply with schedule for follow-up visits;
•adult patient

Exclusion Criteria

•corneal astigmatism \> 1.00 D
•irregular astigmatism
•diabetic retinopathy
•iris neovascularisation
•serious intraoperative complications
•congenital eye abnormality
•uncontrolled glaucoma or glaucoma with changes in optical nerve and visual field
•pseudoexfoliation syndrome
•amblyopia
•uveitis
+13 more criteria

Locations (3)

Borsod-Abaúj-Zemplén Vármegyei Központi Kórház és Egyetemi Oktatókórház

Miskolc, BAZ Vármegye, Hungary

Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház

Győr, Győr-Moson-Sopron Vármegye, Hungary

Retinaszerviz Kft.

Veszprém, Veszprém Vármegye, Hungary

Key Dates

Start Date

December 2, 2020

Primary Completion Date

November 21, 2023

Completion Date

January 24, 2024

Last Updated

October 15, 2024

Enrollment

ACTUAL participants

Conditions

CataractPresbyopiaAmetropia

Interventions

VFQ- 25 (Visual Function Questionnaire)

BEHAVIORAL

Optical Biometry

DIAGNOSTIC_TEST

Slit lamps / Fundoscopy / Biomicroscopy

DIAGNOSTIC_TEST

UDVA

DIAGNOSTIC_TEST

CDVA

DIAGNOSTIC_TEST

UIVA / DCIVA

DIAGNOSTIC_TEST

UNVA / DCNVA

DIAGNOSTIC_TEST

Manifest Refraction

DIAGNOSTIC_TEST

IOP

DIAGNOSTIC_TEST

VADC

DIAGNOSTIC_TEST

CSDC

DIAGNOSTIC_TEST

CSV-1000

DIAGNOSTIC_TEST

Tear film stability

DIAGNOSTIC_TEST

IOL implantation

DEVICE

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

NCT06979752

Glaucoma, Open Angle, Pseudo-exfoliativeCataract

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RECRUITING

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

NCT07362043

Cataract Surgery

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparative Analysis of the Visual Performance and Patient Satisfaction After Cataract Surgery With Implantation of a Medicontur Monofocal (877PAY) or a Medicontur Extended Depth of Focus (877PEY) IOL

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses

IC-8 Apthera IOL New Enrollment Post Approval Study

HUD Surgical Guidance for Toric Alignment

PRO-232 in Patients Subjected to Cataract Surgery