Retrospective, Non-interventional Clinical Investigation of the Safety and Performance of 640AD Monofocal Intraocular Lens
NCT ID: NCT06578910
Last Updated: 2024-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2023-05-23
2024-04-25
Brief Summary
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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 640AD IOLs mono- or binocularly between December 2021 - December 2022.
Data from five visits will be collected:
* Baseline preoperative (maximum 30 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
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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640AD
80 patients (105 eyes) implanted with 640AD IOL monocularly or binocularly
Standard of care
12 months after the IOL implantation: measurement of intraocular pressure, slitlamp and fundus examination, visual acuity, manifest refraction.
Patient satisfaction questionnare
VFQ- 25 (Visual Function Questionnare) to be completed during 12 month visit.
Interventions
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Standard of care
12 months after the IOL implantation: measurement of intraocular pressure, slitlamp and fundus examination, visual acuity, manifest refraction.
Patient satisfaction questionnare
VFQ- 25 (Visual Function Questionnare) to be completed during 12 month visit.
Eligibility Criteria
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Inclusion Criteria
* Pseudophakic patients implanted with 640AD monofocal IOLs (implanted between December 2021 - December 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 with the following condition(s) at the time of the baseline visit:
* Corneal astigmatism \> 1.5 D
* 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.)
18 Years
ALL
No
Sponsors
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Medicontur Medical Engineering Ltd
INDUSTRY
Responsible Party
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Locations
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SZTE ÁOK Szent-Györgyi Albert Klinikai Központ Szemészeti Klinika
Szeged, , Hungary
Countries
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Other Identifiers
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M_640AD_HU_2204
Identifier Type: -
Identifier Source: org_study_id
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