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Completed

NCT Number: NCT06578910

Retrospective, Non-interventional Clinical Investigation of the Safety and Performance of 640AD Monofocal Intraocular Lens

Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOL) is indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), secondarily to removal of the crystalline lens.

The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power.

The study will be performed partially as a retrospective study with patients enrolled who had been implanted with 640AD IOLs mono- or binocularly between December 2021 - December 2022.

Data from five visits will be collected:

* Baseline preoperative (maximum 30 days prior to surgery)- retrospective * IOL implantation Day 0 - retrospective * Postoperative visit at Day 1 (+/- 0 days) - retrospective * Postoperative visit at 1 month (+/- 2 weeks) - retrospective * Postoperative visit at 12 months (+/- 3 months) - consent and prospective visit

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Pathological Conditions, Signs and Symptoms Pseudophakia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SZTE ÁOK Szent-Györgyi Albert Klinikai Központ Szemészeti Klinika

Szeged, 6720, Hungary

Who can participate

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

Inclusion criteria

  • Adult males or females above 18 years of age;
  • Pseudophakic patients implanted with 640AD monofocal IOLs (implanted between December 2021 - December 2022);
  • Diagnosis of cataract and/or ametropia (hyperopia, myopia);
  • Subject who has signed an informed consent form.
  • Patients who have participated in all visits that are subject to retrospective data collection.

Exclusion criteria

  • Patients who are not targeted to emmetropia ( outside -0,5 and 0,5 D)
  • Patients with the following condition(s) at the time of the baseline visit:
  • Corneal astigmatism > 1.5 D
  • Uncontrolled diabetic retinopathy
  • Iris neovascularization
  • Congenital eye abnormality
  • Uncontrolled glaucoma
  • Pseudoexfoliation syndrome
  • Amblyopia
  • Uveitis
  • AMD (advanced AMD)
  • Retinal detachment
  • Prior ocular surgery in personal medical history
  • Previous laser treatment
  • Corneal diseases
  • Severe retinal diseases (dystrophy, degeneration)
  • High myopia
  • Inadequate visualization of the fundus on preoperative examination
  • Patients deemed by the clinical investigator because of any systemic disease
  • Pregnancy
  • Eye trauma in medical history
  • Current use of systemic steroids or topical ocular medication
  • Patients with any eye condition that could affect vision in the opinion of the investigator at the time of the 12-month follow-up: (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.)

Treatment and study plan

Standard of care

Diagnostic Test

12 months after the IOL implantation: measurement of intraocular pressure, slitlamp and fundus examination, visual acuity, manifest refraction.

Patient satisfaction questionnare

Other

VFQ- 25 (Visual Function Questionnare) to be completed during 12 month visit.

Primary outcomes

  1. Monocular corrected distance visual acuity (CDVA)

    Time frame: 12 months postoperatively

    To compare monocular corrected distance visual acuity (CDVA) between 12 months postoperative and preoperative results.

Secondary outcomes

  1. Monocular uncorrected distance visual acuity (UDVA)

    Time frame: 12 months postoperatively

    To compare monocular uncorrected distance visual acuity (UDVA) at 12 months postoperative and preoperative status.

  2. UDVA and CDVA

    Time frame: 12 months postoperatively

    To compare percentage of eyes that achieve monocular UDVA and monocular CDVA within logMAR 0.0 or 0.3 at 12 months postoperative and preoperative status.

  3. Manifest residual refraction

    Time frame: 12 months postoperatively

    To compare residual SPH at 12 months postoperative and preoperative status. (Residual CYL and axis are not applicable, as it is a monofocal IOL, that does not correct astigmatism)

  4. Patient satisfaction

    Time frame: 12 months postoperatively

    Visual Function Questionnaire 25 (National Eye Institute) is used to evaluate overall satisfaction, subjective perception of colour perception and scotopic vision at 12 months postoperatively. The results are evaluated according to the official evaluation guide.

Other outcomes

  1. Safety outcome - Intraoperative complications

    Time frame: Day1 postoperatively

    Intraoperative complications of cataract surgery

    • Posterior capsular or zonular rupture
    • Vitreous loss/anterior vitrectomy or aspiration
    • Iris/ciliary body injury
    • Loss of nuclear material into vitreous
    • Suprachoroidal haemorrhage
    • Retrobulbar haemorrhage

  2. Safety outcome - Postoperative complications

    Time frame: Month1 postoperatively

    Postoperative complications of cataract surgery

    • Cystoid macular oedema
    • Iris abnormalities
    • Corneal oedema
    • 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 outcome - Complications of IOL implantation

    Time frame: Month12 postoperatively

    Complications of IOL implantation

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

Sponsors and collaborators

Lead sponsor

Medicontur Medical Engineering Ltd

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 30, 2024
Registry last updated
Aug 30, 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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