Clinical trial NCT05750225: Clinical Investigation of the Safety and Performance of Model 690AD and Model 690ADY Monofocal Intraocular Lens Implantation
Official title: Retrospective, Non-interventional, Comparative Clinical Investigation of the Safety and Performance of 690AD and 690ADY Monofocal Intraocular Lens Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Pseudophakia
Intraocular Lens Complication
Intraocular Lens Opacification
Lead sponsor: Medicontur Medical Engineering Ltd
Sponsor class: INDUSTRY
First posted: 2023-03-01
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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 690AD or 690ADY IOL implantation.

Brief summary: Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOLs) are 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 690AD or 690ADY IOLs mono- or binocularly between September 2021 - March 2022.

Data from five visits will be collected:

* Baseline preoperative (maximum 90 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 690AD or 690ADY monofocal IOLs (implanted between September 2021 - March 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.
* Patients with the following condition(s) at the time of the baseline visit:

  * Corneal astigmatism \> 1.0 diopter
  * 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: CDVA
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: UDVA
timeFrame: 12 months postoperatively
measure: UDVA and CDVA
timeFrame: 12 months postoperatively
measure: Spherical Equivalent
timeFrame: 12 months postoperatively
measure: Patient satisfaction
timeFrame: 12 months postoperatively
measure: Cylinder
timeFrame: 12 months postoperatively
measure: Axis of the eye
timeFrame: 12 months postoperatively
Other outcomes:
measure: Intraoperative complications of cataract surgery
timeFrame: at Day1 postoperatively
measure: Postoperative complications of cataract surgery
timeFrame: at Month1 postoperatively
measure: Complications of IOL implantation
timeFrame: at Month12 postoperatively
Locations:
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem, Klinikai Központ Szemészeti Klinika
Study officials:
References: