Clinical trial NCT06642779: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Presbyopia
Ametropia
Keywords: Intraocular lens
monofocal IOL
EDOF
Lead sponsor: Medicontur Medical Engineering Ltd
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (18 years old and older) with cataract and/or ametropia (hyperopia, myopia), who hace signed the informed consent form and undergone binocular implantation with the investigational device (877PEY) or the comparator device (877PAY).

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


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
* 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.

Primary outcomes:
measure: DCIVA
timeFrame: measured at month 1, month 3, month 6 and month 12
Secondary outcomes:
measure: UDVA/CDVA
timeFrame: measured at month 1, month 3, month 6 and month 12
measure: VADC
timeFrame: measured at month 3, month 6 and month 12
measure: CSDC
timeFrame: measured at month 6 and month 12
measure: Patient satisfaction
timeFrame: Evaluated at month 3 and month 12
measure: CSV-1000
timeFrame: measured at month 3, month 6 and month 12
Other outcomes:
measure: Safety (intraoperative complications of cataract surgery)
timeFrame: Up to day 1 postoperatively
measure: Safety (postoperative complications of cataract surgery)
timeFrame: Up to month 1 postoperatively
measure: Safety (complications of IOL implantation)
timeFrame: Up to month 12 postoperatively
Locations:
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Vármegyei Központi Kórház és Egyetemi Oktatókórház
state: BAZ Vármegye
city: Győr
country: Hungary
facility: Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
state: Győr-Moson-Sopron Vármegye
city: Veszprém
country: Hungary
facility: Retinaszerviz Kft.
state: Veszprém Vármegye
Study officials:
affiliation: Retinaszerviz Kft. (8200 Veszprém, Vörösmarty tér 6, Hungary)
name: József F Győry, MD
role: PRINCIPAL_INVESTIGATOR
References: