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

NCT05750225 | Completed

• 1 other identifier: M_690AD/690ADY_HU_2203
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 2

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

Conditions

Cataract; Pseudophakia; Intraocular Lens Complication; Intraocular Lens Opacification

Outcome Measures

Primary Outcomes (1)

• CDVA

  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.

  12 months postoperatively

Secondary Outcomes (6)

• UDVA

  12 months postoperatively

• UDVA and CDVA

  12 months postoperatively

• Spherical Equivalent

  12 months postoperatively

• Patient satisfaction

  12 months postoperatively

• Cylinder

  12 months postoperatively

Other Outcomes (3)

• Intraoperative complications of cataract surgery

  at Day1 postoperatively

• Postoperative complications of cataract surgery

  at Month1 postoperatively

• Complications of IOL implantation

  at Month12 postoperatively

Study Arms (2)

690AD IOL

50 eyes /patients implanted with 690AD IOL

Other: Standard of care; Other: Patient satisfaction questionnare

690ADY IOL

50 eyes /patients implanted with 690ADY IOL

Other: Standard of care; Other: Patient satisfaction questionnare

Interventions

Standard of care OTHER

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

690AD IOL; 690ADY IOL

Patient satisfaction questionnare OTHER

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

690AD IOL; 690ADY IOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Medicontur Medical Engineering Ltd: lead

Study Sites (2)

Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház

Nyíregyháza, 4400, Hungary

Location

Pécsi Tudományegyetem, Klinikai Központ Szemészeti Klinika

Pécs, 7632, Hungary

Location

MeSH Terms

Conditions

Cataract; Pseudophakia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 1, 2023
• Study Start: February 2, 2023
• Primary Completion: June 7, 2023
• Study Completion: June 7, 2023
• Last Updated: June 11, 2024

Record last verified: 2023-05

Locations

HU (2)