Clinical trial NCT06578910: Retrospective, Non-interventional Clinical Investigation of the Safety and Performance of 640AD Monofocal Intraocular Lens
Official title: Retrospective, Non-interventional Clinical Investigation of the Safety and Performance of 640AD Monofocal Intraocular Lens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Pseudophakia
Keywords: Intraocular lens
Ametropia - correction
Presbyopia- correction
Lead sponsor: Medicontur Medical Engineering Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (18 years old and older) with cataract and/or ametropia (hyperopia, myopia), who have undergone monocular or binocular implantation with the 640AD IOL model.

Brief summary: 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


Eligibility criteria: 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.)

Primary outcomes:
measure: Monocular corrected distance visual acuity (CDVA)
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: Monocular uncorrected distance visual acuity (UDVA)
timeFrame: 12 months postoperatively
measure: UDVA and CDVA
timeFrame: 12 months postoperatively
measure: Manifest residual refraction
timeFrame: 12 months postoperatively
measure: Patient satisfaction
timeFrame: 12 months postoperatively
Other outcomes:
measure: Safety outcome - Intraoperative complications
timeFrame: Day1 postoperatively
measure: Safety outcome - Postoperative complications
timeFrame: Month1 postoperatively
measure: Safety outcome - Complications of IOL implantation
timeFrame: Month12 postoperatively
Locations:
city: Szeged
country: Hungary
facility: SZTE ÁOK Szent-Györgyi Albert Klinikai Központ Szemészeti Klinika
Study officials:
References: