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Completed

NCT Number: 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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Borsod-Abaúj-Zemplén Vármegyei Központi Kórház és Egyetemi Oktatókórház, Miskolc, BAZ Vármegye, Hungary

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VFQ- 25 (Visual Function Questionnaire)

Behavioral

VFQ-25 questionnaire was used to evaluate patient satisfaction at the M3 and M12 visits.

Optical biometry

Diagnostic Test

Axial length, anterior chamber depth and corneal keratometric values K1-K2. All these parameters were measured at the screening visit and at the month 3 follow-up visit, using the ARGOS® Biometer or the ANTERION® Cataract App

Slit lamps / Fundoscopy / Biomicroscopy

Diagnostic Test

The fundus and other ocular structures, such as the cornea, anterior chamber, iris, pupil, crystalline lens / IOL alignment, corpus ciliare and choroid were examined at screening visit, on the day of the surgery, and at the follow up visits D1, M1, M3, M6, and M12, using the slit lamp binocular indirect ophthalmoscopy.

UDVA

Diagnostic Test

Monocular and binocular Uncorrected Distance Visual Acuity (UDVA) was evaluated at all visits (preoperative, D1, M1, M3, M6 and M12), using the ETDRS chart.

CDVA

Diagnostic Test

Monocular and binocular Corrected Distance Visual Acuity (UDVA) was evaluated at all visits (preoperative, D1, M1, M3, M6 and M12), using the ETDRS chart.

UIVA / DCIVA

Diagnostic Test

Uncorrected and Distance Corrected Intermediate Visual acuity (UIVA / DCIVA) was evaluated postoperatively at M1, M3, M6 and M12, using an intermediate chart from 67 cm.

UNVA / DCNVA

Diagnostic Test

Uncorrected and Distance Corrected Near Visual acuity (UNVA / DCNVA) was evaluated postoperatively at M1, M3, M6 and M12, using a near chart from 40 cm.

Manifest Refraction

Diagnostic Test

Manifest refraction was the monocular subjective refraction (Sph, Cyl, Axis) giving the best distance corrected visual acuity. It was measured at the screening visit and the follow-up visits Day 1, Month 1, Month 3, Month 6 and Month 12.

IOP

Diagnostic Test

Intraocular pressure (IOP) was measured at all visits (preoperative, D1, M1, M3, M6 and M12), using a non-contact tonometer.

VADC

Diagnostic Test

Visual Acuity Defocus Curve (VADC) was taken monocularly at M3, monocularly and binocularly at M6 and binocularly at M12, using the Multifocal Lens analyzer - MLA application.

CSDC

Diagnostic Test

Contrast Sinsitivity Defocus Curve (CSDC) was taken under photopic conditions at M6 and M12, using the Multifocal Lens Analyzer - MLA application

CSV-1000

Diagnostic Test

Contrast Sensitivity was measured using the CSV-1000 with distance correction in place at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd). Measurements were taken under four different light conditions:

  • Photopic (M3 monocular and binocular, M6 binocular and M12 monocular)
  • Mesopic (M6 binocular)
  • Photopic with backlight (M6 binocular)
  • Mesopic with backlight (M6 binocular)

Tear film stability

Diagnostic Test

Tear film stability was assessed at screening visit and at follow-up visits M1, M3, M6, and M12 using the non-invasive Tear break Up Time (TBUT) with fluorescein dye.

IOL Implantation

Device

The investigational device (877PEY) and the comparator (877PAY) intraocular lens models were implanted, using sutureless, small-incision phacoemulsification surgery.

Primary outcomes

  1. DCIVA

    Time frame: measured at month 1, month 3, month 6 and month 12

    distance corrected intermediate visual acuity

Secondary outcomes

  1. UDVA/CDVA

    Time frame: measured at month 1, month 3, month 6 and month 12

    uncorrected and corrected distance visual acuity

  2. VADC

    Time frame: measured at month 3, month 6 and month 12

    visual acuity defocus curves

  3. CSDC

    Time frame: measured at month 6 and month 12

    contrast sensitivity defocus curves

  4. Patient satisfaction

    Time frame: Evaluated at month 3 and month 12

    presence of visual disturbances (glares, halos), evaluated with the VFQ-25 questionnaire.

  5. CSV-1000

    Time frame: measured at month 3, month 6 and month 12

    Contrast sensitivity measured with the CSV-1000 standardized auto-calibrating vision testing instrument

Other outcomes

  1. Safety (intraoperative complications of cataract surgery)

    Time frame: Up to day 1 postoperatively

    • Posterior capsular or zonular rupture
    • Vitreous loss/anterior vitrectomy or aspiration
    • Iris/ciliary body injury
    • Loss of nuclear material into vitreous
    • Suprachoroidal haemorrhage
    • Retrobulbar hemorrhage
  2. Safety (postoperative complications of cataract surgery)

    Time frame: Up to month 1 postoperatively

    • Cystoid macular edema
    • Iris abnormalities
    • Corneal edema
    • Wound leak or rupture
    • IOL dislocation, removal, or exchange
    • Inflammation (Endophthalmitis, anterior chamber cells, anterior chamber flare, hypopyon)
    • Retinal tear, break, or detachment
    • Persistent iritis
    • Elevated intraocular pressure
    • Pupillary block
    • Cornea status
  3. Safety (complications of IOL implantation)

    Time frame: Up to month 12 postoperatively

    • Posterior capsular opacification (PCO)
    • Opacification, IOL discoloration

Sponsors and collaborators

Lead sponsor

Medicontur Medical Engineering Ltd

Industry

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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