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

Medicontur

Status: Completed

Conditions: Pseudophakia; Cataract

Treatments: Diagnostic Test: Standard of care; Other: Patient satisfaction questionnare

Study type: Observational

Funder types: Industry

Identifiers

NCT06578910

M_640AD_HU_2204

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

80 participants in 1 patient group

640AD

Description:

80 patients (105 eyes) implanted with 640AD IOL monocularly or binocularly

Treatment:

Other: Patient satisfaction questionnare

Diagnostic Test: Standard of care