NCT06642779CompletedNot 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 enrollmentStarted: December 2, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 64
- Locations
- 3
- Primary Endpoint
- DCIVA
Study 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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
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)
Investigators
Study Sites (3)
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