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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 690AD IOL | 50 eyes /patients implanted with 690AD IOL |
| |
| 690ADY IOL | 50 eyes /patients implanted with 690ADY IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care | Other | 12 months after the IOL implantation: measurement of intraocular pressure, slitlamp and fundus examination, visual acuity, manifest refraction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| UDVA and CDVA |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Postoperative complications of cataract surgery |
Inclusion Criteria:
Exclusion Criteria:
- Patients who are not targeted to emmetropia.
Patients with the following condition(s) at the time of the baseline visit:
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.);
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Adults (18 years old and older) with cataract and/or ametropia (hyperopia, myopia), who have undergone monocular or binocular 690AD or 690ADY IOL implantation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház | Nyíregyháza | 4400 | Hungary | |||
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| Patient satisfaction questionnare | Other | VFQ- 25 (Visual Function Questionnare) to be completed during 12 month visit. |
|
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 |
| 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 |
| 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 |
| Cylinder | Cylinder shall be used to calculate manifest residual refraction. | 12 months postoperatively |
| Axis of the eye | Axis of the eye shall be used to calculate manifest residual refraction. | 12 months postoperatively |
To verify that the frequency of the following complications does not exceed those stated in Acceptance criteria.
| at Month1 postoperatively |
| Complications of IOL implantation | To verify that the frequency of the following complications does not exceed those stated in Acceptance criteria. | at Month12 postoperatively |
| Pécsi Tudományegyetem, Klinikai Központ Szemészeti Klinika |
| Pécs |
| 7632 |
| Hungary |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D019591 | Pseudophakia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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