Cataract Clinical Trial
Official title:
Clinical Outcome After Implantation of Medicontur Multifocal, Toric Intraocular Lens Liberty 677MTY: Rotational Stability, Visual Outcomes, Patients' Satisfaction, YAG Capsulotomy Rate
Verified date | May 2023 |
Source | Medicontur Medical Engineering Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to evaluate visual outcomes, patient satisfaction and YAG capsulotomy rate after implantation of a multifocal toric lens- Liberty 677MTY - manufactured by Medicontur Ltd. (Zsámbék, Hungary),
Status | Enrolling by invitation |
Enrollment | 30 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Exclusion Criteria: - astigmatism less than 1 dpt - irregural astigmatism - diabetic retinopathy - iris neovascularisation - serious intraoperative complications - congenital eye abnormality - glaucoma - pseudoexfoliation syndrom - amblyopia - uveitis - long-term anti-inflammatory treatment - AMD (advanced AMD) - retinal detachment - prior ocular surgery in personal medical history - corneal diseases - severe retinal diseases (dystrophy, degeneration) - severe myopia (if required IOL power is lower than 10 D) - inadequate visualization of the fundus on preoperative examination - patients deemed by the clinical investigator because of any systemic disease. - eye trauma in medical history intraoperative exclusions: - tear in capsulorhexis - zonular dehiscence - posterior capsular rupture - vitreous loss and other unexpected surgical complication |
Country | Name | City | State |
---|---|---|---|
Hungary | Semmelweis University, Department of Ophthalmology | Budapest |
Lead Sponsor | Collaborator |
---|---|
Medicontur Medical Engineering Ltd |
Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rotational stability | Rotational stability will be measured using slit lamp images of the implanted lens on day one, seven, month one, three and one year postoperatively | 1 year | |
Secondary | Visual outcome | Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart at month one, three and one year postoperatively | 1 year | |
Secondary | Contrast sensitivity | Contrast sensitivity will be assessed by using the CSV-1000 method in photopic and mesopic light condition three month and one year after implantation | 1 year | |
Secondary | YAG capsulatomy | The rate of YAG capsulatomy will be assessed during the one year follow-up | 1 year | |
Secondary | Patient satisfaction | Patient satisfaction will be assessed by using the VFQ-25 questionnaire three month and one year postoperatively | 1 year |
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