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

Completed

• Conditions: Pseudophakia; Cataract
• Interventions: Diagnostic Test: Standard of care; Other: Patient satisfaction questionnare

• Registration Number: NCT06578910
• Lead Sponsor: Medicontur Medical Engineering Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-23
• Primary Completion: 2024-04-25
• Study Completion: 2024-04-25
• Study First Submitted: 2024-06-10
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-28
• Last Update Submitted: 2024-08-28
• Study First Posted: 2024-08-30
• Last Update Posted: 2024-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
640AD	Standard of care	80 patients (105 eyes) implanted with 640AD IOL monocularly or binocularly
640AD	Patient satisfaction questionnare	80 patients (105 eyes) implanted with 640AD IOL monocularly or binocularly

Primary Outcome Measures

Name	Time	Method
Monocular corrected distance visual acuity (CDVA)	12 months postoperatively	To compare monocular corrected distance visual acuity (CDVA) between 12 months postoperative and preoperative results.

Secondary Outcome Measures

Name	Time	Method
Monocular uncorrected distance visual acuity (UDVA)	12 months postoperatively	To compare monocular uncorrected distance visual acuity (UDVA) at 12 months postoperative and preoperative status.
UDVA and CDVA	12 months postoperatively	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.
Manifest residual refraction	12 months postoperatively	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)
Patient satisfaction	12 months postoperatively	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.

Trial Locations

Locations (1)

SZTE ÁOK Szent-Györgyi Albert Klinikai Központ Szemészeti Klinika; 🇭🇺 Szeged, Hungary