Clinical Investigation of the Safety and Performance of 690AD and 690ADY Monofocal Intraocular Lens Implantation
Study Details
Study Description
Brief Summary
Medicontur hydrophilic posterior chamber monofocal 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:
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Baseline preoperative (maximum 90 days prior to surgery)- retrospective
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IOL implantation Day 0 - retrospective
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Postoperative visit at Day 1 (+/- 0 days) - retrospective
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Postoperative visit at 1 month (+/- 2 weeks) - retrospective
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Postoperative visit at 12 months (+/- 3 months) - consent and prospective visit
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- CDVA [12 months postoperatively]
Monocular corrected distance visual acuity (CDVA)
Secondary Outcome Measures
- UDVA [12 months postoperatively]
Monocular unorrected distance visual acuity (UDVA)
- Spherical Equivalent [12 months postoperatively]
Spherical Equivalent shall be used to calculate manifest residual refraction.
- Patient satisfaction [12 months postoperatively]
Subjective perception of colour perception and scotopic vision shall be assessed by interviewing the patient using VFQ-25 questionnare.
- Cylinder [12 months postoperatively]
Cylinder shall be used to calculate manifest residual refraction.
- Axis of the eye [12 months postoperatively]
Axis of the eye shall be used to calculate manifest residual refraction.
Other Outcome Measures
- Intraoperative complications of cataract surgery [at Day1 postoperatively]
- Postoperative complications of cataract surgery [at Month1 postoperatively]
- Complications of IOL implantation [at Month12 postoperatively]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult males or females above 18 years of age;
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Pseudophakic patients implanted with 690AD or 690ADY monofocal IOLs (implanted between September 2021 - March 2022);
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Diagnosis of cataract and/or ametropia (hyperopia, myopia);
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Subject who has signed an informed consent form.
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Patients who have participated in all visits that are subject to retrospective data collection.
Exclusion Criteria:
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- Patients who are not targeted to emmetropia.
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Patients with the following condition(s) at the time of the baseline visit:
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Corneal astigmatism > 1.0D
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Uncontrolled diabetic retinopathy
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Iris neovascularization
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Congenital eye abnormality
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Uncontrolled glaucoma
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Pseudoexfoliation syndrome
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Amblyopia
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Uveitis
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AMD (advanced AMD)
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Retinal detachment
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Prior ocular surgery in personal medical history
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Previous laser treatment
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Corneal diseases
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Severe retinal diseases (dystrophy, degeneration)
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High myopia
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Inadequate visualization of the fundus on preoperative examination
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Patients deemed by the clinical investigator because of any systemic disease
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Pregnancy
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Eye trauma in medical history
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Current use of systemic steroids or topical ocular medication
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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.);
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház | Nyíregyháza | Hungary | 4400 | |
| 2 | Pécsi Tudományegyetem, Klinikai Központ Szemészeti Klinika | Pécs | Hungary | 7632 |
Sponsors and Collaborators
- Medicontur Medical Engineering Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M_690AD/690ADY_HU_2203