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

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

Study Overview

• Status: Completed
• Conditions: Cataract; Pseudophakia
• Intervention / Treatment: Other: Patient satisfaction questionnare; Diagnostic test: Standard of care

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Hungary
  • Szeged, Hungary, 6720
    • SZTE ÁOK Szent-Györgyi Albert Klinikai Központ Szemészeti Klinika

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
  • Severe retinal diseases (dystrophy, degeneration)
  • High myopia
  • Inadequate visualization of the fundus on preoperative examination
  • Patients deemed by the clinical investigator because of any systemic disease
  • Pregnancy
  • Eye trauma in medical history
  • Current use of systemic steroids or topical ocular medication
• Patients with any eye condition that could affect vision in the opinion of the investigator at the time of the 12-month follow-up: (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
640AD; 80 patients (105 eyes) implanted with 640AD IOL monocularly or binocularly	Other: Patient satisfaction questionnare; VFQ- 25 (Visual Function Questionnare) to be completed during 12 month visit.; Diagnostic test: Standard of care; 12 months after the IOL implantation: measurement of intraocular pressure, slitlamp and fundus examination, visual acuity, manifest refraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular uncorrected distance visual acuity (UDVA)	To compare monocular uncorrected distance visual acuity (UDVA) at 12 months postoperative and preoperative status.	12 months postoperatively
UDVA and CDVA	To compare percentage of eyes that achieve monocular UDVA and monocular CDVA within logMAR 0.0 or 0.3 at 12 months postoperative and preoperative status.	12 months postoperatively
Manifest residual refraction	To compare residual SPH at 12 months postoperative and preoperative status. (Residual CYL and axis are not applicable, as it is a monofocal IOL, that does not correct astigmatism)	12 months postoperatively
Patient satisfaction	Visual Function Questionnaire 25 (National Eye Institute) is used to evaluate overall satisfaction, subjective perception of colour perception and scotopic vision at 12 months postoperatively. The results are evaluated according to the official evaluation guide.	12 months postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome - Intraoperative complications	Intraoperative complications of cataract surgery; Posterior capsular or zonular rupture; Vitreous loss/anterior vitrectomy or aspiration; Iris/ciliary body injury; Loss of nuclear material into vitreous; Suprachoroidal haemorrhage; Retrobulbar haemorrhage	Day1 postoperatively
Safety outcome - Postoperative complications	Postoperative complications of cataract surgery; Cystoid macular oedema; Iris abnormalities; Corneal oedema; Wound leak or rupture; IOL dislocation, removal, or exchange; Inflammation (Endophthalmitis, anterior chamber cells, anterior chamber flare, hypopyon); Retinal tear, break, or detachment; Persistent iritis; Elevated intraocular pressure; Pupillary block; Cornea status	Month1 postoperatively
Safety outcome - Complications of IOL implantation	Complications of IOL implantation; Posterior capsular opacification (PCO); Opacification, IOL discoloration	Month12 postoperatively

Collaborators and Investigators

• Sponsor: Medicontur Medical Engineering Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): April 25, 2024

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Intraocular lens; Ametropia - correction; Presbyopia- correction
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Pseudophakia
• Other Study ID Numbers: M_640AD_HU_2204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No