ClinicalTrials.gg
RecruitingNCT06238271Updated Feb 2, 2024

Evaluation of the Long-term Efficacy and Safety of Monofocal Plate Haptic Intraocular Lens

An interventional study of Acriva BB UDM 611 in Lens Implantation, Intraocular and Cataract, sponsored by Yuzuncu Yıl University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-02.

Sponsored by Yuzuncu Yıl University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Nov 2024, 2 years ago, but the record still lists the study as recruiting.
  • Registered 1 year 2 months after the study started (first participant enrolled Nov 2022, registered Jan 2024).
  • Started Nov 2022; still recruiting 3 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This study was planned to be performed on 300 eyes with surgical indication due to cataracts in Van Yüzüncü Yıl University Faculty of Medicine Ophthalmology Outpatient Clinic. Uncorrected and best-corrected visual acuity, subjective refraction, slit-light biomicroscopy, optical biometry, anterior segment optical coherence tomography, intraocular pressure, endothelial cell count in the pre-and postoperative (1st, 3rd, and 12th months) controls of the patients. Fundus examination will be performed, and postoperative complications and accompanying ocular pathologies will be recorded. Data before and after surgery effectiveness will be evaluated. Reliability will be interpreted by considering postoperative complications.

02

Conditions studied

  • Lens Implantation, Intraocular
  • Cataract

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Keywords

  • Cataract
  • Intraocular lens implantation
  • Phacoemulsification
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 300 is above the median of 79 across 1,092 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient informed of the consequences and constraints of the protocol and who has given his/her written ;
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    UDM 611

    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

  • DeviceAcriva BB UDM 611

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

06

What researchers measure

Primary outcomes

  1. Visual acuity

    Monocular best corrected distance visual acuity

    Time frame: 12 to 18 months after surgery

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06238271
Collaborators
VSY Biotechnology
Responsible party
Erbil Seven (MD, Associate Professor, Yuzuncu Yıl University) — Principal investigator
First posted
Feb 2, 2024
Start date
Nov 23, 2022
Primary completion
Nov 2024 (estimated)
Completion
May 2025 (estimated)
Last update
Feb 2, 2024

Study contacts

Erbil Seven, MD, Associate Professor
Contact
erbilseven@gmail.com
+90 (432) 2150474

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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