Status:
COMPLETED
Retrospective, Non-interventional Clinical Investigation of the Safety and Performance of 640AD Monofocal Intraocular Lens
Lead Sponsor:
Medicontur Medical Engineering Ltd
Conditions:
Cataract
Pseudophakia
Eligibility:
All Genders
18+ years
Brief Summary
Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOL) is indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), secondarily to re...
Eligibility Criteria
Inclusion
- Adult males or females above 18 years of age;
- 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
- Patients who are not targeted to emmetropia ( outside -0,5 and 0,5 D)
- 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.)
Key Trial Info
Start Date :
May 23 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 25 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06578910
Start Date
May 23 2023
End Date
April 25 2024
Last Update
August 30 2024
Active Locations (1)
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1
SZTE ÁOK Szent-Györgyi Albert Klinikai Központ Szemészeti Klinika
Szeged, Hungary, 6720