NCT04756908

Brief Summary

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 14, 2023

Status Verified

June 1, 2022

Enrollment Period

3.2 years

First QC Date

February 12, 2021

Last Update Submit

February 13, 2023

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

  • Visual Acuity

    6 Months

  • Adverse event rates

    12 Months

Study Arms (3)

Opira AIOL

EXPERIMENTAL
Device: Cataract Surgery

Monofocal AIOL

ACTIVE COMPARATOR
Device: Cataract Surgery

Multifocal AIOL

ACTIVE COMPARATOR
Device: Cataract Surgery

Interventions

Cataract SurgeryDEVICE

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

Monofocal AIOLMultifocal AIOLOpira AIOL

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Comorbidities affecting visual acuity, IOP \> 22mmHg, congential cataract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinica 2020

San José, Costa Rica

RECRUITING

Codet Vision Institute

Tijuana, Mexico

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Paul Rhee, O.D

CONTACT

9492944191prhee@forsightv6.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 16, 2021

Study Start

October 8, 2020

Primary Completion

January 1, 2024

Study Completion

June 1, 2024

Last Updated

February 14, 2023

Record last verified: 2022-06

Locations

CO(1)ME(1)