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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05750225
Other study ID # M_690AD/690ADY_HU_2203
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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 Completed
Enrollment 52
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.);

Study Design


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
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