NCT05748275已完成不适用
Randomized Trial Comparing Prediction Accuracy of Two Swept Source Optical Coherence Tomography Biometers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean Absolute Prediction Error (D)
研究概览
简要总结
To assess if the Alcon Argos Biometer utilizing the Barrett Universal II formula for IOL calculations can give a non-inferior outcome when compared to the Zeiss IOL master 700 utilizing the (PCA) with the Barrett Universal II (TK) formula, when comparing the (mean absolute prediction error of the predicted target spherical equivalencies).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 接受健康志愿者
- 否
入选标准
- •Age: 50-85 years old
- •Clinically Significant Cataracts that interfere with daily activities
- •Patient is able to understand and able to consent to informed consent
- •Patient is able to come to all postoperative visits and agrees to follow up at 30 days -2/+14 days
- •Patient undergoing cataract surgery, with implantation of the Alcon SN60WF lens in the capsular bag.
排除标准
- •Axial Length < 22.00 and > 26.00
- •Corneal Astigmatism > +1.00 Diopters
- •CCTS: < 490 and > 600
- •Prior Refractive Surgery: RK, PRK, LASIK, INTACTS
- •History of contact lens use: Soft lenses within 2 months of surgery, RGP within 60 months of surgery
- •Corneal Disease: Keratoconus, Corneal Dystrophies, Any prior corneal Surgery, Prior infections
- •Retinal Disease: Macular Pathology, CSCR, CME, Macular Degeneration, Drusen, Retinal Detachment, TPPV, SB, prior IVT, Prior PRP or Focal Laser, Diabetic Retinopathy
- •History of Uveitis
- •POAG: Undergoing any concomitant MIGS procedure- iStent, Omni, iTrack, Hydrus, etc
- •Enrollment in any prior clinical trial within 2 years
- •Systemic Disease that in the investigator's opinion may affect outcome
- •Currently Pregnant or Breastfeeding
- •Severe Dry Eye
- •Tear Osmolarity > 320mOsms/L (Moderate)
- •Any Surgical Complication(s)
- •IOL implanted outside of the capsular bag /capsular damage /weakness /CTR placement
结局指标
主要结局
Mean Absolute Prediction Error (D)
时间窗: 1 month postoperatively
次要结局
- Percentage of Eyes With Absolute Prediction Error 0.5 D or Less(1 month postoperatively)
- Median Absolute Prediction Error (D)(1 month postoperatively)
研究者
研究点 (1)
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