A PROSPECTIVE CONTROLLED CLINICAL STUDY TO EVALUATE THE SAFETY AND PERORMANCE OF THE HOYA SURGICAL OPTICS VIVINEX®GEMETRIC™ PRE-LOADED INTRAOCULAR LENS

Phase 2

• Conditions: h25; Senile cataract

• Registration Number: DRKS00015270
• Lead Sponsor: Hoya Medical Singapore PTE. LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 509

Inclusion Criteria

1.Adult subjects with a minimum age of 22 years
2.Planned for mono- or bilateral lens extraction (e.g. cataract, dysfunctional lens syndrome) and implantation of the investigational IOL
3.Planned for bilateral lens extraction (e.g. cataract, dysfunctional lens syndrome) and implantation of the control IOL
4.Clear intraocular media other than cataract
5.Expected postoperative corrected distance visual acuity of 0,1 logMAR (0,8 decimal) or better in the study eye/s
6.Subjects who require a spherical equivalent lens power from +13.0 D to 27,5 D in the study eye/s
7.Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
8.Ability to read and to consent to participation in study
9.Signed informed consent

Exclusion Criteria

1.Patients who need a legal representative or cannot read or understand the ICF
2.Endothelial cell count < 2000 cells/mm2
3.Intraocular inflammation or recurrent ocular inflammatory condition
4.Previous intraocular and corneal surgery (e.g. LASIK, LASEK, RK, PRK, etc.), including corneal refractive surgery, or retinal surgery on the study eyes
5.Lentodonesis or other capsular bag pathologies (e.g. after traumatic cataract) in the study eye/s
6.Instability of keratometry or biometry measurements
7.Strabismus, amblyopia or single eye status
8.Pupil abnormalities (e.g. non-reactive, fixed pupils, or abnormally shaped pupils)
9.Irregular astigmatism
10.More than 1.0 D of expected postoperative corneal astigmatism
11.Requiring an intraocular lens power outside the available range of +13.0 to + 27,5 D
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 in the study eye
13.Presence of corneal pathology affecting topography (e.g. stromal, epithelial or endothelial dystrophy)
14.Acute, chronic, or uncontrolled systemic or ocular disease or illness that would increase the operative risk or confound the outcome of the study (e.g. poorly-controlled diabetes, immunocompromised, connective tissue disease, uncontrolled ocular hypertension, glaucomatous changes in the retina, chronic iritis/uveitis, retinal vessel disease, etc.) or where healing processes are compromised
15.Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study 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 study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
16.Subjects with 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
17.Use of systemic or ocular medications that may affect vision
18.Serious dry eye symptoms that could lead to refractive changes/fluctuations and to significant patients’ complaints
19.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
20.Inability to focus, fixate or maintain binocular vision for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
21.Desire for monovision correction
22.Pregnant, plan to become pregnant, are lactating or have another condition associated with the fluctuation of hormones that could lead to significant refractive changes
23.Are concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days
24.Patients with nocturnal or glare-prone
occupational activities (e.g. pilots, taxi drivers, etc.)
25.Subjects should be discontinued if conditions are present at the time of surgery:
-Zonular instability
-Need for iris manipulation
-Capsular fibrosis or other opacities which might in

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint: Secondary Surgical Intervention due to optic design. Primary Performance Endpoints: Visual acuities.<br>