Cataract, Lens Implantation, Intraocular
Conditions
Keywords
Cataract, Intraocular lens implantation, Phacoemulsification
Brief summary
Our study aims to determine the efficacy and safety of the monofocal plate haptic intraocular lens to be implanted in patients planning for cataract surgery and to determine the complications that may develop due to the lens.
Detailed description
This study was planned to be performed on 300 eyes with surgical indication due to cataracts in Van Yüzüncü Yıl University Faculty of Medicine Ophthalmology Outpatient Clinic. Uncorrected and best-corrected visual acuity, subjective refraction, slit-light biomicroscopy, optical biometry, anterior segment optical coherence tomography, intraocular pressure, endothelial cell count in the pre-and postoperative (1st, 3rd, and 12th months) controls of the patients. Fundus examination will be performed, and postoperative complications and accompanying ocular pathologies will be recorded. Data before and after surgery effectiveness will be evaluated. Reliability will be interpreted by considering postoperative complications.
Interventions
DEVICEAcriva BB UDM 611
Acriva BB UDM 611 intraocular lens will be implanted into the capsular bag in patients who undergo cataract extraction with phacoemulsification.
Sponsors
VSY Biotechnology
Yuzuncu Yil University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent; * Patients of any gender * Assured follow-up examinations * Biometry measurement preferably compatible with the Lenstar evaluation; * IOL implanted into the capsular bag with IOL model Acriva BB UDM 611 (UVE material) in one or both eyes
Exclusion criteria
* BCVA not available preoperatively or better than 0.3 logMAR pre-op * Patients unable to meet the limitations of the protocol or likely to non-cooperation during the trial * Patients with peroperative complications (Such as capsulorhexis problems that affect centralization, failure of the IOL implanting into the bag, posterior capsular rupture, iris damage, vitreous loss, IOL damage, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | 12 to 18 months after surgery | Monocular best corrected distance visual acuity |
Countries
Turkey (Türkiye)
Contacts
Primary ContactErbil Seven, MD, Associate Professor
Outcome results
None listed