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

Cataract Clinical Trial

Official title:

Retrospective, Non-interventional, Comparative Clinical Investigation of the Safety and Performance of 690AD and 690ADY Monofocal Intraocular Lens Implantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05750225
• Other study ID #: M_690AD/690ADY_HU_2203
• Status: Active, not recruiting
• Start date: February 2, 2023
• Est. completion date: June 7, 2023

Study information

• Verified date: May 2023
• Source: Medicontur Medical Engineering Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 7, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.);

Related Conditions & MeSH terms

• Cataract
• Intraocular Lens Complication
• Intraocular Lens Opacification
• Pseudophakia

Intervention

Other:
• Standard of care
12 months after the IOL implantation: measurement of intraocular pressure, slitlamp and fundus examination, visual acuity, manifest refraction.
• Patient satisfaction questionnare
VFQ- 25 (Visual Function Questionnare) to be completed during 12 month visit.

Locations

Country	Name	City	State
Hungary	Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház	Nyíregyháza
Hungary	Pécsi Tudományegyetem, Klinikai Központ Szemészeti Klinika	Pécs

Sponsors (1)

Lead Sponsor	Collaborator
Medicontur Medical Engineering Ltd

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intraoperative complications of cataract surgery	To verify that the frequency of the following complications does not exceed those stated in Acceptance criteria.	at Day1 postoperatively
Other	Postoperative complications of cataract surgery	To verify that the frequency of the following complications does not exceed those stated in Acceptance criteria.	at Month1 postoperatively
Other	Complications of IOL implantation	To verify that the frequency of the following complications does not exceed those stated in Acceptance criteria.	at Month12 postoperatively
Primary	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	UDVA	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.	12 months postoperatively
Secondary	UDVA and CDVA	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.	12 months postoperatively
Secondary	Spherical Equivalent	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.	12 months postoperatively
Secondary	Patient satisfaction	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.	12 months postoperatively
Secondary	Cylinder	Cylinder shall be used to calculate manifest residual refraction.	12 months postoperatively
Secondary	Axis of the eye	Axis of the eye shall be used to calculate manifest residual refraction.	12 months postoperatively