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Medicontur preloaded hydrophobic monofocal toric intraocular lenses (IOLs) are indicated to improve vision at far distance in adults with or without cataract and correction of pre-existing corneal astigmatism 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 investigation will be performed as a prospective, non-comparative, single arm study with a single center design. Patients will be enrolled who are assigned to be implanted with the 877PTY IOLs mono- or binocularly between January 2024 - June 2025.
Data from six visits will be collected:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 877PTY | 100 patients/eyes implanted with 877PTY IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 877PTY | Device | IOL implantation with 6-month follow-up period Monocular UDVA/CDVA Manifest Refraction (SPH, CYL, SEQ) Optical Biometry, Keratometry (K1, K2, AXL, ACD) IOL axis orientation determination Visual function questionnaire Glistening evaluation Tonometry Slit-Lamp examination Fundus visualization |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Performance Endpoint - CDVA | Visual acuity: monocular CDVA at 6 months after IOL implantation | 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Performance Endpoint - UDVA | Visual acuity: monocular UDVA at 6 months after IOL implantation | 6 months postoperatively |
| Secondary Performance Endpoint - Subjective CYL | Subjective (manifest) cylinder and keratometric cylinder of the eye at 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints - Intraoperative complications | Intraoperative complications of cataract surgery
| Up to day 1 postoperatively |
Inclusion Criteria:
Exclusion Criteria:
Intraoperative exclusions: the presence of the following intraoperative exclusion criteria will lead to the exclusion of the subject:
- Any unexpected or serious intraoperative complication that makes IOL implantation impossible or results in implantation of another type of IOL that is outside the scope of this clinical trial.
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Aphakic adult patients (18 years old and older), with cataract and corneal astigmatism who aspire to have improved uncorrected distance vision and reduction of the residual refractive cylinder and assigned to monocular or binocular implantation with 877PTY IOL.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház | Győr | 9024 | Hungary |
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|
| 6 months postoperatively |
| Secondary Performance Endpoint - Residual CYL and SEQ | Residual manifest cylinder and spherical equivalent at 6 months postoperatively; | 6 months postoperatively |
| Secondary Performance Endpoint - Rotational stability | IOL rotational stability at 6 months after IOL implantation; | 6 months postoperatively |
| Secondary Performance Endpoint - Injector handling | Ease of IOL implantation and positioning at surgery; | 6 months postoperatively |
| Secondary Performance Endpoint - Patient satisfaction (VFQ-25) | Patient-reported visual functions: overall global vision rating, difficulty with near and distance vision activities, social functioning and role limitations, dependency on others, mental health symptoms due to vision, driving difficulties, limitations with peripheral and color vision, and ocular pain evaluated by visual function questionnaire at 6 months after IOL implantation. | 6 months postoperatively |
| Secondary Performance Endpoint - Glistening | Glistening rate and severity at 6 months after IOL implantation | 6 months postoperatively |
| Safety Endpoints - Postoperative complications |
Postoperative complications of cataract surgery
|
| Up to month 1 postoperatively |
| Safety Endpoints - Complications of IOL implantation | Complications of IOL implantation
| Up to month 6 postoperatively |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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