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

NCT ID: NCT05750225

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2023-06-07

Brief Summary

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

Conditions

Cataract; Pseudophakia; Intraocular Lens Complication; Intraocular Lens Opacification

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

690AD IOL

50 eyes /patients implanted with 690AD IOL

Standard of care

Intervention Type: OTHER

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

Patient satisfaction questionnare

Intervention Type: OTHER

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

690ADY IOL

50 eyes /patients implanted with 690ADY IOL

Standard of care

Intervention Type: OTHER

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

Patient satisfaction questionnare

Intervention Type: OTHER

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

Interventions

Standard of care

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

Intervention Type: OTHER

Patient satisfaction questionnare

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

Intervention Type: OTHER

Eligibility Criteria

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.);

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medicontur Medical Engineering Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház

Nyíregyháza, , Hungary

Pécsi Tudományegyetem, Klinikai Központ Szemészeti Klinika

Pécs, , Hungary

Countries

Hungary

Other Identifiers

M_690AD/690ADY_HU_2203

Identifier Type: -

Identifier Source: org_study_id