Cataract, Corneal Astigmatism
Conditions
Keywords
cataract, intraocular lens (IOL), astigmatism correction, aphakic
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)
Interventions
DEVICE877PTY
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
Sponsors
Medicontur Medical Engineering Ltd
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Performance Endpoint - CDVA | 6 months postoperatively | Visual acuity: monocular CDVA at 6 months after IOL implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Performance Endpoint - Residual CYL and SEQ | 6 months postoperatively | Residual manifest cylinder and spherical equivalent at 6 months postoperatively; |
| Secondary Performance Endpoint - Injector handling | 6 months postoperatively | Ease of IOL implantation and positioning at surgery; |
| Secondary Performance Endpoint - Patient satisfaction (VFQ-25) | 6 months postoperatively | 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. |
| Secondary Performance Endpoint - Glistening | 6 months postoperatively | Glistening rate and severity at 6 months after IOL implantation |
| Secondary Performance Endpoint - UDVA | 6 months postoperatively | Visual acuity: monocular UDVA at 6 months after IOL implantation |
| Secondary Performance Endpoint - Subjective CYL | 6 months postoperatively | Subjective (manifest) cylinder and keratometric cylinder of the eye at 6 months postoperatively |
| Secondary Performance Endpoint - Rotational stability | 6 months postoperatively | IOL rotational stability at 6 months after IOL implantation; |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoints - Complications of IOL implantation | Up to month 6 postoperatively | Complications of IOL implantation * Posterior capsular opacification (PCO) * Opacification, IOL discoloration |
| Safety Endpoints - Intraoperative complications | Up to day 1 postoperatively | 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 |
| Safety Endpoints - Postoperative complications | Up to month 1 postoperatively | 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 |
Countries
Hungary
Outcome results
None listed