Comparative Analysis of the Visual Performance and Patient Satisfaction After Cataract Surgery With Implantation of a Medicontur Monofocal (877PAY) or a Medicontur Extended Depth of Focus (877PEY) IOL
- Conditions
- CataractPresbyopiaAmetropia
- Registration Number
- NCT06642779
- Lead Sponsor
- Medicontur Medical Engineering Ltd
- Brief Summary
The purpose of this multi-center, prospective, randomized, comparative clinical investigation was to evaluate and compare the visual performance at far, intermediate and near distances, the presence of photopic phenomena and patient satisfaction after cataract surgery in patients implanted binocularly with a Medicontur monofocal (877PAY) or a Medicontur extended depth of focus (877PEY) IOL models.
The visit schedule included a total of 6 visits, in addition to the IOL implantation surgery, with the listed follow-up timeline:
* screening and baseline assessments
* day 0 (IOL implantation surgery)
* day 1
* month 1
* month 3
* month 6
* month 12
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- cataractous patients who wish to be partly spectacle independent
- cataractous lens changes as demonstrated by best corrected visual acuity of 20/40 or worse either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract-related visual symptoms*
- best corrected visual acuity to be better than 20/25 (0.1 logMAR) after cataract removal and IOL implantation*
- ≤ 1.0 D of preoperative keratometric astigmatism;
- clear intraocular media other than cataract;
- given written informed consent by subject;
- subjects are willing and able to comply with schedule for follow-up visits;
- adult patient
- corneal astigmatism > 1.00 D
- irregular astigmatism
- diabetic retinopathy
- iris neovascularisation
- serious intraoperative complications
- congenital eye abnormality
- uncontrolled glaucoma or glaucoma with changes in optical nerve and visual field
- pseudoexfoliation syndrome
- amblyopia
- uveitis
- long-term anti-inflammatory treatment
- 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 exclusion criteria:
-
tear in capsulorhexis*
-
zonular dehiscence*
-
posterior capsular rupture vitreous loss and other unexpected surgical complication*
- According to coordinator investigator's decision, the marked inclusion and exclusion criteria were not applied.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DCIVA measured at month 1, month 3, month 6 and month 12 distance corrected intermediate visual acuity
- Secondary Outcome Measures
Name Time Method UDVA/CDVA measured at month 1, month 3, month 6 and month 12 uncorrected and corrected distance visual acuity
VADC measured at month 3, month 6 and month 12 visual acuity defocus curves
CSDC measured at month 6 and month 12 contrast sensitivity defocus curves
Patient satisfaction Evaluated at month 3 and month 12 presence of visual disturbances (glares, halos), evaluated with the VFQ-25 questionnaire.
CSV-1000 measured at month 3, month 6 and month 12 Contrast sensitivity measured with the CSV-1000 standardized auto-calibrating vision testing instrument
Trial Locations
- Locations (3)
Borsod-Abaúj-Zemplén Vármegyei Központi Kórház és Egyetemi Oktatókórház
🇭🇺Miskolc, BAZ Vármegye, Hungary
Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
🇭🇺Győr, Győr-Moson-Sopron Vármegye, Hungary
Retinaszerviz Kft.
🇭🇺Veszprém, Veszprém Vármegye, Hungary