Safety and Effectiveness of the Opira AIOL in Comparison to Commercial IOLs in Patients Undergoing Cataract Surgery

NCT ID: NCT04756908

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-08

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a clinical trial comparing an investigative accommodative IOL and two commercial IOLs in patients with cataracts undergoing primary cataract surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective, multicenter clinical study comparing the safety and performance of the Opira accommodative IOL, a commercial monofocal IOL, and a commercial multifocal IOL. Eligible patients with bilateral cataracts will undergo cataract surgery implanting one of three study lenses, and will be followed postoperatively for 24 months

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Opira AIOL

Group Type EXPERIMENTAL

Cataract Surgery

Intervention Type DEVICE

The surgical procedure in which the natural crystalline lens is removed and replaced with a lens implant.

Monofocal AIOL

Group Type ACTIVE_COMPARATOR

Cataract Surgery

Intervention Type DEVICE

The surgical procedure in which the natural crystalline lens is removed and replaced with a lens implant.

Multifocal AIOL

Group Type ACTIVE_COMPARATOR

Cataract Surgery

Intervention Type DEVICE

The surgical procedure in which the natural crystalline lens is removed and replaced with a lens implant.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cataract Surgery

The surgical procedure in which the natural crystalline lens is removed and replaced with a lens implant.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male and female subjects aged 50-75 with bilateral cataracts, good potential vision, and clear intraocular media other than lens opacity

Exclusion Criteria

* Comorbidities affecting visual acuity, IOP \> 22mmHg, congential cataract
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

FSV6, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinica 2020

San José, , Costa Rica

Site Status RECRUITING

Codet Vision Institute

Tijuana, , Mexico

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Costa Rica Mexico

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Paul Rhee, O.D

Role: CONTACT

9492944191

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nadja Dodero

Role: primary

Martha Federico

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CIP-04

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Photopic and Mesopic Multifocal IOL Performance
NCT06978556 ACTIVE_NOT_RECRUITING