NCT06238271

Brief Summary

Our study aims to determine the efficacy and safety of the monofocal plate haptic intraocular lens to be implanted in patients planning for cataract surgery and to determine the complications that may develop due to the lens.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

November 23, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 2, 2024

Status Verified

January 1, 2024

Enrollment Period

1.9 years

First QC Date

January 25, 2024

Last Update Submit

January 25, 2024

Conditions

Lens Implantation, IntraocularCataract

Keywords

CataractIntraocular lens implantationPhacoemulsification

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Monocular best corrected distance visual acuity

    12 to 18 months after surgery

Study Arms (1)

UDM 611

EXPERIMENTAL

Acriva BB UDM 611 intraocular lens will be implanted into the capsular bag in patients who undergo cataract extraction with phacoemulsification.

Device: Acriva BB UDM 611

Interventions

Acriva BB UDM 611DEVICE

Acriva BB UDM 611 intraocular lens will be implanted into the capsular bag in patients who undergo cataract extraction with phacoemulsification.

UDM 611

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
  • Patients of any gender
  • Assured follow-up examinations
  • Biometry measurement preferably compatible with the Lenstar evaluation;
  • IOL implanted into the capsular bag with IOL model Acriva BB UDM 611 (UVE material) in one or both eyes

You may not qualify if:

  • BCVA not available preoperatively or better than 0.3 logMAR pre-op
  • Patients unable to meet the limitations of the protocol or likely to non-cooperation during the trial
  • Patients with peroperative complications (Such as capsulorhexis problems that affect centralization, failure of the IOL implanting into the bag, posterior capsular rupture, iris damage, vitreous loss, IOL damage, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yuzuncu Yil University

Van, 65090, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Central Study Contacts

Erbil Seven, MD, Associate Professor

CONTACT

+90 (432) 2150474erbilseven@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associate Professor

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 2, 2024

Study Start

November 23, 2022

Primary Completion

November 1, 2024

Study Completion

May 1, 2025

Last Updated

February 2, 2024

Record last verified: 2024-01

Locations

TU(1)