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

Medicontur

Status

Completed

Conditions

Pseudophakia

Intraocular Lens Complication

Cataract

Intraocular Lens Opacification

Treatments

Behavioral: Patient satisfaction questionnare

Diagnostic Test: Standard of care

Study type

Observational

Funder types

Industry

Identifiers

NCT06578923

M_690AD/690ADY_HU_2302

Details and patient eligibility

About

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

Enrollment

51 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.);