Evaluation of the visual performance of Clareon intraocular lens after bilateral implantation in patients targeted for mini-monovision - A prospective, single center, longitudinal study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Visual Acuity: Snellen’s visual acuity charts will be used for distance and Notation (N) charts were used for intermediate (66 centimetres) and near (40 centimetres) visual acuity.
研究概览
简要总结
Purpose: To assess the visual outcomes in patients bilaterally implanted with novel Clareon® intraocular lens when targeting mini monovision post-operatively. Setting: The study was conducted at Laxmi Eye Institute; it is a tertiary care eye institution in Panvel, India. Design: This is an investigator initiated, prospective, single-centre longitudinal study of 45 patients to assess the visual outcomes in patients who were implanted with Clareon ® IOL bilaterally. Methods: Patients with corneal astigmatism of ≤ 0.75 D who underwent bilateral cataract surgery with pseudophakic mini-monovision and implanted with novel Clareon® intraocular lens were included. Patients having post op manifest refraction >± 0.25 D in the dominant eye and <− 0.5 D or >− 0.75 D in the non-dominant eye were excluded. The main study outcomes were assessed at 1 and 3 months; it included uncorrected visual acuities assessment, defocus curve, and patient reported spectacle use. Results: The mean (SD) binocular distance corrected intermediate visual acuity at 3 months was 0.22 (0.09) LogMAR. At 3 months, 54% of patients enjoyed 0.4 LogMAR or better BUCNVA. The defocus curve showed good distance and intermediate visual acuity with > 0.2 LogMAR vision from +0.50 D to − 1.50 D. We found a positive correlation between the Q value of the dominant eye and the BCIVA at 3 months postoperatively, however it was not statistically significant. The Q value was more negative when the intermediate vision was closer to 0 LogMAR. Post operatively, at 3 months, 95% patients did not need glasses for distance and intermediate vision and 73% of patients were comfortable for intermediate vision without glasses all the time. Conclusion: Mini-monovision with Clareon® monofocal IOL implantation can offer overall satisfactory vision for far and intermediate distances with minimal need for use of spectacles for near vision.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients who have been implanted bilaterally with Clareon intraocular lens (IOL; model SY60CL; Alcon Vision LLC) Uncomplicated age related cataract who underwent uncomplicated bilateral cataract surgery by phacoemulsification technique Preoperative & postoperative corneal astigmatism of ≤ 0.75 D Willing to provide consent for follow-up Completed all the study follow-up as per the protocol.
排除标准
- •Subjects with prior history of any intraocular surgery Subject who underwent any additional procedures during cataract surgery Subjects who underwent complicated cataract surgery Subjects who had any post-operative complications Any active ocular disease (Diabetic retinopathy, macular degeneration, glaucoma with field defects and irregular corneal astigmatism) Post op manifest refraction(Spherical Equivalent) > +/-0.25 D in the dominant eye and < -0.5 D or >-0.75 D in the non-dominant eye Subject who is not willing to sign Informed Consent Form for the study.
结局指标
主要结局
Visual Acuity: Snellen’s visual acuity charts will be used for distance and Notation (N) charts were used for intermediate (66 centimetres) and near (40 centimetres) visual acuity.
时间窗: Screening | Day 1 assessment | Day 15 assessment | Day 30 assessment | Day 90 Assessment
次要结局
- Contrast sensitivity(High Order aberrations)
