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Not Yet Recruiting NCT05750225

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

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

Sex: All
Ages: 18 Years – N/A
Enrollment: 100
Sponsor: Medicontur Medical Engineering Ltd

Location: Hungary

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:Baseline preoperative (maximum 90 days prior to surgery)- retrospectiveIOL implantation Day 0 - retrospectivePostoperative visit at Day 1 (+/- 0 days) - retrospectivePostoperative visit at 1 month (+/- 2 weeks) - retrospectivePostoperative visit at 12 months (+/- 3 months) - consent and prospective visit

Eligibility Criteria

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 > 1.0DUncontrolled diabetic retinopathyIris neovascularizationCongenital eye abnormalityUncontrolled glaucomaPseudoexfoliation syndromeAmblyopiaUveitisAMD (advanced AMD)Retinal detachmentPrior ocular surgery in personal medical historyPrevious laser treatmentCorneal diseasesSevere retinal diseases (dystrophy, degeneration)High myopiaInadequate visualization of the fundus on preoperative examinationPatients deemed by the clinical investigator because of any systemic diseasePregnancyEye trauma in medical historyCurrent use of systemic steroids or topical ocular medicationPatients 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.);

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Source: ClinicalTrials.gov (NCT05750225). StuddyBuddy aggregates publicly available trial information.