ACTRN12624000490572尚未招募Unknown
A Prospective, Randomised Investigation to Evaluate and Compare Performance and Safety of the HOYA Vivinex™ Gemetric™ Plus Toric Preloaded IOLs with the Alcon AcrySof® IQ PanOptix® Toric Trifocal IOLs in adults planned for cataract surgery and implantation of IOLs
HOYA Medical Singapore Pte. Ltd.0 个研究点目标入组 200 人开始时间: 2024年4月22日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
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
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Adult subjects with a minimum age of 18 years
- •2. Planned for unilateral or bilateral cataract surgery and implantation of IOLs
- •3. Pre-operative regular corneal astigmatism greater than 0.75 diopter (D) requiring treatment with the toric models of the study lens
- •4. Clear intraocular media other than cataract
- •5. Expected postoperative corrected distance visual acuity of 0.3 logMAR or better
- •6. Subjects who require a spherical equivalent lens power from +10.00D to +30.00D and a maximum toric lens power of +3.75D at IOL plane
- •7. Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures.
排除标准
- •Participants shall not be/ not have:
- •1. Preoperative CDVA better than 0.3 LogMar (< 0.3 LogMAR) assessed by ETDRS visual chart
- •2. Corneal endothelial cell count < 2000 cells/mm2
- •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 surgery excluding laser treatment of peripheral retinal regions not affecting vision in the opinion of the investigator
- •5. Lentodonesis2 or other capsular bag pathologies (e.g., after traumatic cataract)
- •6. Strabismus, amblyopia, or single eye status,
- •7. Pupil abnormalities (e.g., non-reactive, fixed pupils, or abnormally shaped pupils)
- •8. Keratoconus or irregular corneal astigmatism as estimated by surgeon (e.g., angle steep/flat not equal to 90° in 3mm zone; asymmetric power distribution)
- •9. 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
- •10. Presence of corneal pathology affecting topography (e.g., stromal, epithelial or endothelial dystrophy)
- •11. Previous retinal detachment or vitreous detachment impacting visual acuity and/or requiring treatment
- •12. Acute, chronic, or uncontrolled systemic or ocular disease or illness in the opinion of the investigator that 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 on the optic nerve, chronic iritis/uveitis, retinal vessel disease, etc.) or where healing processes are compromised
- •13. Diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) 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.)
- •14. 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
- •15. Use of systemic or ocular medications that may affect vision
- •16. Serious dry eye symptoms that could lead to refractive changes/fluctuations and to significant subjects’ complaints
- •17. Prior or current use of any medication (e.g., a1-blocker such as tamsulosin or silodosin) 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
- •18. Inability to focus, fixate or maintain binocular vision for prolonged periods of time (e.g., due to strabismus, nystagmus, Parkinson disease, etc.)
- •19. Pregnant, plan to become pregnant, lactating or have another condition associated with the fluctuation of hormones that could lead to significant refractive changes
- •20. Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days
研究者
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