Clinical trial NCT06578884: A Prospective Clinical Investigation to Evaluate the Safety and Performance of 877PTY Toric IOL for Visual Correction of Corneal Astigmatism
Official title: A Prospective Clinical Investigation to Evaluate the Safety and Performance of 877PTY Toric IOL for Visual Correction of Corneal Astigmatism
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cataract
Corneal Astigmatism
Keywords: cataract
intraocular lens (IOL)
astigmatism correction
aphakic
Lead sponsor: Medicontur Medical Engineering Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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)


Eligibility criteria: Inclusion Criteria:

* adult patients (18 years old and older);
* cataract and/or corneal astigmatism diagnosis;
* indication for cataract surgery or refractive lens exchange;
* recommended cylinder correction with toric IOL with cylinder power ≥1.0D;
* clear intraocular media other than cataract;
* signed informed consent form;

Exclusion Criteria:

* irregular astigmatism;
* patients who are not targeted to emmetropia (predicted residual spherical equivalent and/or astigmatism is out of the range of ±0.5D and ±0.38D respectively);
* any retinopathy or maculopathy that affects the vision;
* iris neovascularization;
* congenital eye abnormality affecting visual performance;
* advanced glaucoma;
* pseudoexfoliation syndrome affecting IOL stability;
* amblyopia;
* uveitis;
* retinal detachment;
* prior ocular surgery in personal medical history;
* irregular corneal curvature or corneal diseases affecting visual performance;
* high myopia (axial length ≥ 26,5 mm);
* inadequate visualization of the fundus on preoperative examination;
* dilated pupil size not large enough to visualize toric IOL axis markings postoperatively based on the Investigator's decision;
* eye trauma in medical history;
* instability of keratometry or biometry measurements;
* prior corneal refractive surgery such as LASIK, PRK, or SMILE;
* patients deemed ineligible by the investigator because of any systemic disease or treatment;
* pregnancy or lactation;
* current use of systemic steroids or external ophthalmic drugs;
* concurrent participation in another drug or device investigation.

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.

Primary outcomes:
measure: Primary Performance Endpoint - CDVA
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Secondary Performance Endpoint - UDVA
timeFrame: 6 months postoperatively
measure: Secondary Performance Endpoint - Subjective CYL
timeFrame: 6 months postoperatively
measure: Secondary Performance Endpoint - Residual CYL and SEQ
timeFrame: 6 months postoperatively
measure: Secondary Performance Endpoint - Rotational stability
timeFrame: 6 months postoperatively
measure: Secondary Performance Endpoint - Injector handling
timeFrame: 6 months postoperatively
measure: Secondary Performance Endpoint - Patient satisfaction (VFQ-25)
timeFrame: 6 months postoperatively
measure: Secondary Performance Endpoint - Glistening
timeFrame: 6 months postoperatively
Other outcomes:
measure: Safety Endpoints - Intraoperative complications
timeFrame: Up to day 1 postoperatively
measure: Safety Endpoints - Postoperative complications
timeFrame: Up to month 1 postoperatively
measure: Safety Endpoints - Complications of IOL implantation
timeFrame: Up to month 6 postoperatively
Locations:
city: Győr
country: Hungary
facility: Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
Study officials:
References: