Status:
COMPLETED
Retrospective, Non-interventional, Comparative Clinical Investigation of the Safety and Performance of 690AD and 690ADY Monofocal Intraocular Lens Implantation With Extended Patient Enrolment
Lead Sponsor:
Medicontur Medical Engineering Ltd
Conditions:
Cataract
Pseudophakia
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.);
Key Trial Info
Start Date :
January 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 3 2024
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06578923
Start Date
January 15 2024
End Date
May 3 2024
Last Update
August 30 2024
Active Locations (2)
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1
Szabolcs-Szatmár-Bereg Vármegyei Kórházak és Egyetemi Oktatókórház, Szemészeti Klinika
Nyíregyháza, Hungary, 4400
2
Pécsi Tudományegyetem, Klinikai Központ Szemészeti Klinika
Pécs, Hungary, 7623