A Prospective Clinical Investigation to Evaluate the Safety and Performance of 877PTY Toric IOL for Visual Correction of Corneal Astigmatism
NCT Number: NCT06578884
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Cataract|Corneal Astigmatism
Interventions: DEVICE: 877PTY
Sponsor: Medicontur Medical Engineering Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-16
Completion Date: 2025-06-30
Locations: Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház, Győr, 9024, Hungary

Summary:
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:

* Visit 1: Screening and Baseline (up to 90 days prior to the surgery)
* Visit 2: IOL implantation (Day 0)
* Visit 3: Day 1 post-operatively (+/- 0 day)
* Visit 4: Day 7 post-operatively (+/- 3 days)
* Visit 5: Month 1 post-operatively (+/- 2 weeks)
* Visit 6: Month 6 post-operatively (+/- 1 month)

Primary Outcome Measures: Primary Performance Endpoint - CDVA, Visual acuity: monocular CDVA at 6 months after IOL implantation, 6 months postoperatively
Secondary Outcome Measures: 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, 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
Other Outcome Measures: Safety Endpoints - Intraoperative complications, Intraoperative complications of cataract surgery

* Posterior capsular or zonular rupture
* Vitreous loss/anterior vitrectomy or aspiration
* Iris/ciliary body injury
* Loss of nuclear material into vitreous
* Suprachoroidal haemorrhage
* Retrobulbar haemorrhage, Up to day 1 postoperatively|Safety Endpoints - Postoperative complications, Postoperative complications of cataract surgery

* Cystoid macular oedema
* Iris abnormalities
* Corneal oedema
* Wound leak or rupture
* IOL dislocation, removal, or exchange
* Inflammation (Endophthalmitis, anterior chamber cells, anterior chamber flare, hypopyon)
* Retinal tear, break, or detachment
* Persistent iritis
* Elevated intraocular pressure
* Pupillary block
* Cornea status, Up to month 1 postoperatively|Safety Endpoints - Complications of IOL implantation, Complications of IOL implantation

* Posterior capsular opacification (PCO)
* Opacification, IOL discoloration, Up to month 6 postoperatively