DRKS00024535
Completed
未知
POST MARKET CLINICAL FOLLOW-UP STUDY TO EVALUATE THE HOYA VIVINEXTM GEMETRICTM MULTIFOCAL PRELOADED INTRAOCULAR LENSES - GEMT-102-NINO
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- H25
- Sponsor
- HOYA Surgical Optics GmbH
- Enrollment
- 128
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult subjects with a minimum age of 22 years
- •2\. Planned for bilateral lens extraction (e.g., cataract, dysfunctional lens syndrome) and implantation of the investigational IOL
- •3\. Minimal or regular corneal astigmatism to be treated with either the non\-toric or toric model of the VivinexTM GemetricTM IOL
- •4\. Clear intraocular media other than cataract
- •5\. Expected postoperative binocular corrected distance visual acuity of 0\.1 logMAR (0\.8 decimal) or better
- •6\. Subjects who require a spherical equivalent lens power from \+15\.00D to \+26\.00D and a maximum toric lens power of \+3\.00D at IOL plane (T5\)
- •7\. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
- •8\. Ability to consent to the participation in study
- •9\. Signed informed consent
Exclusion Criteria
- •1\. Subjects who need a legal representative or cannot read or understand the ICF
- •2\. Subjects who need monolateral lens extraction
- •3\. Endothelial cell count \< 2000 cells/mm2
- •4\. Predicted postoperative refractive cylinder (calculated on HOYA Toric Calculator) greater than the effective treatment possibility with the toric Gemetric IOL models (T5 \= 2,08D at corneal plane)
- •5\. Intraocular inflammation or recurrent ocular inflammatory condition
- •6\. Previous intraocular or corneal surgery (e.g. LASIK, LASEK, RK, PRK, etc.), including corneal refractive surgery, or retinal surgery excluding laser treatment of peripheral retinal regions not affecting vision in the opinion of the investigator
- •7\. Lentodonesis or other capsular bag pathologies (e.g. after traumatic cataract)
- •8\. Instability of keratometry or biometry measurements
- •9\. Strabismus, amblyopia, or single eye status
- •10\. Pupil abnormalities (e.g., non\-reactive, fixed pupils, or abnormally shaped pupils)
Outcomes
Primary Outcomes
Not specified
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