NCT06642779
Completed
Not Applicable
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
Medicontur Medical Engineering Ltd3 sites in 1 country64 target enrollmentDecember 2, 2020
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- Medicontur Medical Engineering Ltd
- Enrollment
- 64
- Locations
- 3
- Primary Endpoint
- DCIVA
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •long-term anti-inflammatory treatment
Outcomes
Primary Outcomes
DCIVA
Time Frame: measured at month 1, month 3, month 6 and month 12
distance corrected intermediate visual acuity
Secondary Outcomes
- UDVA/CDVA(measured at month 1, month 3, month 6 and month 12)
- VADC(measured at month 3, month 6 and month 12)
- CSDC(measured at month 6 and month 12)
- Patient satisfaction(Evaluated at month 3 and month 12)
- CSV-1000(measured at month 3, month 6 and month 12)
Study Sites (3)
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