A Prospective Post Market Clinical Follow Up Investigation to Evaluate and Compare Performance of the HOYA Vivinex Impress™ Monofocal Preloaded IOL with Alcon AcrySof® IQ IO

Not Applicable

• Conditions: H25; Senile cataract

• Registration Number: DRKS00026617
• Lead Sponsor: HOYA Surgical Optics GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

1. Adult subjects with a minimum age of 22 years,
2. Planned for bilateral lens extraction (cataract) and implantation of the investigational IOLs,
3. Minimal (<1.0D postop, see Nr.6) and regular corneal astigmatism to be treated with the non-toric HOYA Vivinex™ Impress Monofocal Preloaded IOL (model XY1-EM) or non-toric Alcon AcrySof® IQ IOL (model SN60WF (AU00T0)),
4. Clear intraocular media other than cataract,
5. Expected postoperative binocular corrected distance visual acuity of 0.2 logMAR (0.67 decimal) or better as estimated by surgeon,
6. Less than 1.0 D of expected postoperative corneal astigmatism,
7. Eligible to receive a spherical equivalent lens power from +6.00D to +30.00D,
8. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and clinical investigation visits,
9. Ability to consent to the participation in clinical investigation,
10. Signed informed consent.

Exclusion Criteria

1.A legal representative or cannot read or understand the ICF,
2.Surgery planned for one eye only,
3.Intraocular inflammation or recurrent ocular inflammatory condition,
4.Previous intraocular or corneal surgery (e.g. LASIK, LASEK, RK, PRK, etc.) including corneal refractive surgery or retinal (laser) surgery, excluding laser treatment of peripheral retinal regions not affecting vision in the opinion of the investigator,
5.Lentodonesis or other capsular bag pathologies (e.g., after traumatic cataract),
6.Instability of keratometry or biometry measurements,
7.Strabismus, amblyopia (defined as minimum BCVA of 0.63 decimal or 0.2 logMar in one eye) or single eye status,
8.Pupil abnormalities (e.g., non-reactive, fixed pupils, or abnormally shaped pupils),
9.More than 1.0 D of expected postoperative corneal astigmatism
10.Irregular corneal astigmatism as estimated by surgeon (e.g., angle steep/flat ? 90° in 3mm zone; asymmetric power distribution),
11.Requiring an intraocular lens power outside the available range of +6.00D to +30.00D,
12.Continuous contact lens wearing within 6 months of the preoperative, examination for PMMA contact lenses, within 1 month of the preoperative examination for gas permeable lenses, or within 3 weeks of the preoperative examination for extended-wear and daily-wear soft contact lenses,
13.Presence of corneal pathology affecting topography and vision (e.g., stromal, epithelial or endothelial dystrophy),
14.Acute, chronic, or uncontrolled systemic or ocular disease or illness that in the opinion of the investigator would increase the operative risk or confound the outcome of the clinical investigation (e.g., poorly-controlled diabetes, immuno-compromised, connective tissue disease, uncontrolled ocular hypertension, glaucomatous changes in the retina, chronic iritis/uveitis, retinal vessel disease, etc.) or where healing process is compromised,
15.Diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 0.2 logMAR or worse during the clinical investigation or known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the clinical investigation (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.),
16.Systemic disease that could increase the operative risk or confound the outcome,
17.Conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects,
18.Use of systemic or ocular medications that may affect vision,
19.Serious dry eye symptoms that could lead to refractive changes/ fluctuations and to significant subjects’ complaints,
20.Prior or current use of tamsulosin or silodosin (e.g., Flomax®, Flomaxtra®, Rapaflo®) likely, in the opinion of the investigator, to cause poor dilation or lack of adequate iris structure or floppy iris syndrome to perform standard cataract surgery in the opinion of the investigator,
21.Inability to focus, fixate or do vision tests for prolonged periods of time (e.g., due to strabismus, nystagmus, Parkinson desease,
22.Pregnant, plan to become pregnant, lactating or have another condition associated with the fluctuation of hormones that could lead to significant refractive changes

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary performace endopint:<br>- Mean photopic monocular distance corrected visual acuities (CDVA) at the timepoint of refractive stability (form 4<br><br>Primary safety endpoint:<br>- Rate of postoperative secondary ocular surgical interventions (excluding YAG-laser capsulotomy)

Secondary Outcome Measures

Name	Time	Method
Secondary performance endpoint:<br>Mean photopic monoculat distance corrected intermediate visual acuities (DCIVA) at the timepoint of refractive stability (Form 4)