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

Status: Completed

Conditions: Cataract; Ametropia; Presbyopia

Treatments: Diagnostic Test: CDVA; Diagnostic Test: CSV-1000; Device: IOL implantation; Diagnostic Test: UDVA; Diagnostic Test: UIVA / DCIVA; Behavioral: VFQ- 25 (Visual Function Questionnaire); Diagnostic Test: Slit lamps / Fundoscopy / Biomicroscopy; Diagnostic Test: Tear film stability; Diagnostic Test: IOP; Diagnostic Test: UNVA / DCNVA; Diagnostic Test: Optical Biometry; Diagnostic Test: Manifest Refraction; Diagnostic Test: VADC; Diagnostic Test: CSDC

Study type: Observational

Funder types: Industry

Identifiers

NCT06642779

M_877PAY_877PEY_HU_2020

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

64 participants in 2 patient groups

877PAY (monofocal)

Description:

26 patients (52 eyes) binocularly implanted with the 877PAY monofocal IOL model

Treatment:

Diagnostic Test: CSDC

Diagnostic Test: VADC

Diagnostic Test: Manifest Refraction

Diagnostic Test: UNVA / DCNVA

Diagnostic Test: Optical Biometry

Diagnostic Test: Tear film stability

Diagnostic Test: IOP

Diagnostic Test: Slit lamps / Fundoscopy / Biomicroscopy

Behavioral: VFQ- 25 (Visual Function Questionnaire)

Diagnostic Test: UIVA / DCIVA

Diagnostic Test: UDVA

Device: IOL implantation

Diagnostic Test: CSV-1000

Diagnostic Test: CDVA

877PEY (extended depth of focus)

Description:

38 patients (76 eyes) binocularly implanted with the 877PEY extended depth of focus IOL model

Treatment:

Diagnostic Test: CSDC

Diagnostic Test: VADC

Diagnostic Test: Manifest Refraction

Diagnostic Test: UNVA / DCNVA

Diagnostic Test: Optical Biometry

Diagnostic Test: Tear film stability

Diagnostic Test: IOP

Diagnostic Test: Slit lamps / Fundoscopy / Biomicroscopy

Behavioral: VFQ- 25 (Visual Function Questionnaire)

Diagnostic Test: UIVA / DCIVA

Diagnostic Test: UDVA

Device: IOL implantation

Diagnostic Test: CSV-1000

Diagnostic Test: CDVA