Retrospective, Non-interventional Clinical Investigation of the Safety and Performance of 640AD Monofocal Intraocular Lens

NCT06578910 | Completed

• 1 other identifier: M_640AD_HU_2204
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOL) is indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), secondarily to removal of the crystalline lens. The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power. The study will be performed partially as a retrospective study with patients enrolled who had been implanted with 640AD IOLs mono- or binocularly between December 2021 - December 2022. Data from five visits will be collected:

• Baseline preoperative (maximum 30 days prior to surgery)- retrospective
• IOL implantation Day 0 - retrospective
• Postoperative visit at Day 1 (+/- 0 days) - retrospective
• Postoperative visit at 1 month (+/- 2 weeks) - retrospective
• Postoperative visit at 12 months (+/- 3 months) - consent and prospective visit

Conditions

Cataract; Pseudophakia

Keywords

Intraocular lens; Ametropia - correction; Presbyopia- correction

Outcome Measures

Primary Outcomes (1)

• Monocular corrected distance visual acuity (CDVA)

  To compare monocular corrected distance visual acuity (CDVA) between 12 months postoperative and preoperative results.

  12 months postoperatively

Secondary Outcomes (4)

• Monocular uncorrected distance visual acuity (UDVA)

  12 months postoperatively

• UDVA and CDVA

  12 months postoperatively

• Manifest residual refraction

  12 months postoperatively

• Patient satisfaction

  12 months postoperatively

Other Outcomes (3)

• Safety outcome - Intraoperative complications

  Day1 postoperatively

• Safety outcome - Postoperative complications

  Month1 postoperatively

• Safety outcome - Complications of IOL implantation

  Month12 postoperatively

Study Arms (1)

640AD

80 patients (105 eyes) implanted with 640AD IOL monocularly or binocularly

Diagnostic Test: Standard of care; Other: Patient satisfaction questionnare

Interventions

Standard of care DIAGNOSTIC_TEST

12 months after the IOL implantation: measurement of intraocular pressure, slitlamp and fundus examination, visual acuity, manifest refraction.

640AD

Patient satisfaction questionnare OTHER

VFQ- 25 (Visual Function Questionnare) to be completed during 12 month visit.

640AD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (18 years old and older) with cataract and/or ametropia (hyperopia, myopia), who have undergone monocular or binocular implantation with the 640AD IOL model.

You may qualify if:

• Adult males or females above 18 years of age;
• Pseudophakic patients implanted with 640AD monofocal IOLs (implanted between December 2021 - December 2022);
• Diagnosis of cataract and/or ametropia (hyperopia, myopia);
• Subject who has signed an informed consent form.
• Patients who have participated in all visits that are subject to retrospective data collection.

You may not qualify if:

• Patients who are not targeted to emmetropia ( outside -0,5 and 0,5 D)
• Patients with the following condition(s) at the time of the baseline visit:
• Corneal astigmatism \> 1.5 D
• Uncontrolled diabetic retinopathy
• Iris neovascularization
• Congenital eye abnormality
• Uncontrolled glaucoma
• Pseudoexfoliation syndrome
• Amblyopia
• Uveitis
• AMD (advanced AMD)
• Retinal detachment
• Prior ocular surgery in personal medical history
• Previous laser treatment
• Corneal diseases

Sponsors & Collaborators

• Medicontur Medical Engineering Ltd: lead

Study Sites (1)

SZTE ÁOK Szent-Györgyi Albert Klinikai Központ Szemészeti Klinika

Szeged, 6720, Hungary

Location

MeSH Terms

Conditions

Cataract; Pseudophakia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: August 30, 2024
• Study Start: May 23, 2023
• Primary Completion: April 25, 2024
• Study Completion: April 25, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Locations

HU (1)