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

Study Overview
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Brief Summary
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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

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

Conditions
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Cataract, Pseudophakia, Intraocular Lens Complication, Intraocular Lens Opacification

Intervention / Treatment
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* Other: Standard of care
* Other: Patient satisfaction questionnare


Participation Criteria
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Eligibility Criteria
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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.);

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| 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 |