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

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 June 2022 - September 2023.

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: Diagnostic test: Standard of care; Behavioral: Patient satisfaction questionnare

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Hungary
  • Nyíregyháza, Hungary, 4400
    • Szabolcs-Szatmár-Bereg Vármegyei Kórházak és Egyetemi Oktatókórház, Szemészeti Klinika
  • Pécs, Hungary, 7623
    • Pécsi Tudományegyetem, 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 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 June 2022 - September 2023);
• 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 > 1.0D
  • 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; 35 eyes /patients implanted with 690AD IOL	Diagnostic test: Standard of care; 12 months after the IOL implantation: measurement of intraocular pressure, slitlamp and fundus examination, visual acuity, manifest refraction.; Behavioral: Patient satisfaction questionnare; VFQ- 25 (Visual Function Questionnare) to be completed during 12 month visit.
690ADY; 35 eyes /patients implanted with 690ADY IOL	Diagnostic test: Standard of care; 12 months after the IOL implantation: measurement of intraocular pressure, slitlamp and fundus examination, visual acuity, manifest refraction.; Behavioral: 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
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
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
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
Manifest residual refraction	To compare SPH between groups implanted with 690AD and 690ADY monofocal IOLs 12 months after IOL implantation. CYL and axis are not applicable, as the investigational- and comparator devices are monofocal IOLs, that do 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 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 outcomes - 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 outcomes - 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 outcomes - 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): January 15, 2024
• Primary Completion (Actual): May 3, 2024
• Study Completion (Actual): May 3, 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

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Pseudophakia
• Other Study ID Numbers: M_690AD/690ADY_HU_2302

Drug and device information, study documents

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