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Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOL) is 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 640AD IOLs mono- or binocularly between December 2021 - December 2022.
Data from five visits will be collected:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 640AD | 80 patients (105 eyes) implanted with 640AD IOL monocularly or binocularly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care | Diagnostic Test | 12 months after the IOL implantation: measurement of intraocular pressure, slitlamp and fundus examination, visual acuity, manifest refraction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Monocular corrected distance visual acuity (CDVA) | To compare monocular corrected distance visual acuity (CDVA) between 12 months postoperative and preoperative results. | 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular uncorrected distance visual acuity (UDVA) | To compare monocular uncorrected distance visual acuity (UDVA) at 12 months postoperative and preoperative status. | 12 months postoperatively |
| UDVA and CDVA |
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcome - Intraoperative complications | Intraoperative complications of cataract surgery
| Day1 postoperatively |
Inclusion Criteria:
Exclusion Criteria:
Patients who are not targeted to emmetropia ( outside -0,5 and 0,5 D)
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 implantation with the 640AD IOL model.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SZTE ÁOK Szent-Györgyi Albert Klinikai Központ Szemészeti Klinika | Szeged | 6720 | Hungary |
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| 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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| 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 at 12 months postoperative and preoperative status.
| 12 months postoperatively |
| Manifest residual refraction | To compare residual SPH at 12 months postoperative and preoperative status. (Residual CYL and axis are not applicable, as it is a monofocal IOL, that does not correct astigmatism) | 12 months postoperatively |
| Patient satisfaction | Visual Function Questionnaire 25 (National Eye Institute) is used to evaluate overall satisfaction, subjective perception of colour perception and scotopic vision at 12 months postoperatively. The results are evaluated according to the official evaluation guide. | 12 months postoperatively |
| Safety outcome - Postoperative complications |
Postoperative complications of cataract surgery
|
| Month1 postoperatively |
| Safety outcome - Complications of IOL implantation | Complications of IOL implantation
| Month12 postoperatively |