DRKS00024535已完成未知
POST MARKET CLINICAL FOLLOW-UP STUDY TO EVALUATE THE HOYA VIVINEXTM GEMETRICTM MULTIFOCAL PRELOADED INTRAOCULAR LENSES - GEMT-102-NINO
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 22 Years 至 one（—）
- 性别
- All
入选标准
- •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
排除标准
- •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)
- •11. Irregular astigmatism (axis ? 90 ° in 3 mm zone)
- •12. Requiring an intraocular lens power outside the available range of +15.00D to + 26.00D and a toric lens power of more than 3.00D at IOL plane (T5)
- •13. 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
- •14. Presence of corneal pathology affecting topography (e.g. stromal, epithelial or endothelial dystrophy)
- •15. 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, immuno-compromised, connective tissue disease, uncontrolled ocular hypertension, glaucomatous changes in the retina, chronic iritis/uveitis, retinal vessel disease, etc.) or where healing processes are compromised
- •16. 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 0.2 logMAR 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.)
- •17. 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
- •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
- •21. Inability to focus, fixate or maintain binocular vision for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- •22. Pregnant, plan to become pregnant, 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 participate
研究者
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