Clinical Investigation of the Safety and Performance of Model 690AD and Model 690ADY Monofocal Intraocular Lens Implantation

Retrospective, Non-interventional, Comparative Clinical Investigation of the Safety and Performance of 690AD and 690ADY Monofocal Intraocular Lens Implantation

Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOLs) are 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 690AD or 690ADY IOLs mono- or binocularly between September 2021 - March 2022.

Data from five visits will be collected:

• Baseline preoperative (maximum 90 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; Intraocular Lens Complication; Intraocular Lens Opacification
• Intervention / Treatment: Other: Standard of care; Other: Patient satisfaction questionnare

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Hungary
  • Nyíregyháza, Hungary, 4400
    • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz
  • Pécs, Hungary, 7632
    • Pécsi Tudományegyetem, Klinikai Központ Szemészeti Klinika

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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 690AD or 690ADY IOL implantation.

Description

Inclusion Criteria:

• Adult males or females above 18 years of age;
• Pseudophakic patients implanted with 690AD or 690ADY monofocal IOLs (implanted between September 2021 - March 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.

• Patients with the following condition(s) at the time of the baseline visit:

  • Corneal astigmatism > 1.0 diopter
  • 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

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
690AD IOL; 50 eyes /patients implanted with 690AD IOL	Other: Standard of care; 12 months after the IOL implantation: measurement of intraocular pressure, slitlamp and fundus examination, visual acuity, manifest refraction.; Other: Patient satisfaction questionnare; VFQ- 25 (Visual Function Questionnare) to be completed during 12 month visit.
690ADY IOL; 50 eyes /patients implanted with 690ADY IOL	Other: Standard of care; 12 months after the IOL implantation: measurement of intraocular pressure, slitlamp and fundus examination, visual acuity, manifest refraction.; Other: Patient satisfaction questionnare; VFQ- 25 (Visual Function Questionnare) to be completed during 12 month visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CDVA	Monocular corrected distance visual acuity (CDVA) To compare monocular corrected distance visual acuity (CDVA) between groups implanted with 690AD and 690ADY monofocal IOLs at 12 months postoperatively.	12 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cylinder	Cylinder shall be used to calculate manifest residual refraction.	12 months postoperatively
Axis of the eye	Axis of the eye shall be used to calculate manifest residual refraction.	12 months postoperatively
UDVA	Monocular uncorrected distance visual acuity (UDVA) To compare monocular uncorrected distance visual acuity (UDVA) between groups implanted with 690AD and 690ADY monofocal IOLs 12 months postoperatively.	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 between groups implanted with 690AD and 690ADY monofocal IOLs at 12 months postoperatively.	12 months postoperatively
Spherical Equivalent	Spherical Equivalent shall be used to calculate manifest residual refraction. To compare sphere, cylinder and axis of the eye between groups implanted with 690AD and 690ADY monofocal IOLs 12 months after IOL implantation.	12 months postoperatively
Patient satisfaction	Subjective perception of colour perception and scotopic vision shall be assessed by interviewing the patient using visual function questionnaire (VFQ-25 questionnaire) . To compare overall satisfaction, subjective perception of colour perception and scotopic vision between groups implanted with 690AD and 690ADY, postoperatively at 12 months.	12 months postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative complications of cataract surgery	To verify that the frequency of the following complications does not exceed those stated in Acceptance criteria.	at Day1 postoperatively
Postoperative complications of cataract surgery	To verify that the frequency of the following complications does not exceed those stated in Acceptance criteria.	at Month1 postoperatively
Complications of IOL implantation	To verify that the frequency of the following complications does not exceed those stated in Acceptance criteria.	at Month12 postoperatively

Collaborators and Investigators

• Sponsor: Medicontur Medical Engineering Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Actual): June 7, 2023
• Study Completion (Actual): June 7, 2023

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Pseudophakia
• Other Study ID Numbers: M_690AD/690ADY_HU_2203

Drug and device information, study documents

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