Clinical Investigation of the Safety and Performance of Model 690AD and Model 690ADY Monofocal Intraocular Lens Implantation

Completed

• Conditions: Intraocular Lens Complication; Intraocular Lens Opacification; Pseudophakia; Cataract
• Interventions: Other: Standard of care; Other: Patient satisfaction questionnare

• Registration Number: NCT05750225
• Lead Sponsor: Medicontur Medical Engineering Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-02
• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-03-01
• Status Verified: 2023-05
• Primary Completion: 2023-06-07
• Study Completion: 2023-06-07
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.);

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
690AD IOL	Standard of care	50 eyes /patients implanted with 690AD IOL
690ADY IOL	Standard of care	50 eyes /patients implanted with 690ADY IOL
690AD IOL	Patient satisfaction questionnare	50 eyes /patients implanted with 690AD IOL
690ADY IOL	Patient satisfaction questionnare	50 eyes /patients implanted with 690ADY IOL

Primary Outcome Measures

Name	Time	Method
CDVA	12 months postoperatively	Monocular corrected distance visual acuity (CDVA) To compare monocular corrected distance visual acuity (CDVA) between groups implanted with 690AD and 690ADY monofocal IOLs at 12 months postoperatively.

Secondary Outcome Measures

Name	Time	Method
UDVA	12 months postoperatively	Monocular uncorrected distance visual acuity (UDVA) To compare monocular uncorrected distance visual acuity (UDVA) between groups implanted with 690AD and 690ADY monofocal IOLs 12 months postoperatively.
UDVA and CDVA	12 months postoperatively	To compare percentage of eyes that achieve monocular UDVA and monocular CDVA within logMAR 0.0 or 0.3 between groups implanted with 690AD and 690ADY monofocal IOLs at 12 months postoperatively.
Spherical Equivalent	12 months postoperatively	Spherical Equivalent shall be used to calculate manifest residual refraction. To compare sphere, cylinder and axis of the eye between groups implanted with 690AD and 690ADY monofocal IOLs 12 months after IOL implantation.
Patient satisfaction	12 months postoperatively	Subjective perception of colour perception and scotopic vision shall be assessed by interviewing the patient using visual function questionnaire (VFQ-25 questionnaire) . To compare overall satisfaction, subjective perception of colour perception and scotopic vision between groups implanted with 690AD and 690ADY, postoperatively at 12 months.
Cylinder	12 months postoperatively	Cylinder shall be used to calculate manifest residual refraction.
Axis of the eye	12 months postoperatively	Axis of the eye shall be used to calculate manifest residual refraction.

Trial Locations

Locations (2)

Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház; 🇭🇺 Nyíregyháza, Hungary

Pécsi Tudományegyetem, Klinikai Központ Szemészeti Klinika; 🇭🇺 Pécs, Hungary