Postoperative Rotational Dynamics of Different Toric Intraocular Lens Designs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Absolute rotational misalignment of toric intraocular lens (IOL) measured in degrees
研究概览
简要总结
This prospective comparative cohort study evaluates and compares postoperative rotational stability and time-course dynamics of three commercially available toric intraocular lenses (TECNIS Toric II [ZCU], AcrySof IQ Toric, and AT TORBI 709M) after phacoemulsification cataract surgery. Rotation is quantified by registering postoperative retroillumination photographs to the end-of-surgery baseline using iris/scleral landmarks, with follow-up at postoperative day 1, day 3, week 1, week 2, month 1, and month 3. Associations between rotational outcomes and ocular biometric parameters are analyzed using linear mixed-effects models to inform individualized IOL selection and perioperative management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Outcome assessors were masked to IOL type.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older with age-related cataract scheduled for phacoemulsification cataract surgery.
- •Presence of regular corneal astigmatism requiring toric intraocular lens implantation.
- •Eligible for implantation of one of the three study toric intraocular lenses based on preoperative evaluation.
- •Ability to understand the study procedures and provide written informed consent.
排除标准
- •History of prior ocular surgery in the study eye.
- •History of ocular trauma in the study eye.
- •Irregular corneal astigmatism or corneal pathology affecting reliable biometric measurement.
- •Intraoperative complications, including anterior capsular tear or posterior capsular rupture.
- •Inadequate pupillary dilation during surgery or postoperative examinations.
- •Evidence of zonular weakness, zonular dialysis, or lens subluxation.
- •Active ocular infection or inflammation.
- •Any other ocular or systemic condition judged by the investigator to potentially affect intraocular lens stability or study outcomes.
研究组 & 干预措施
TECNIS Toric II (ZCU)
Participants randomized to this arm receive implantation of the TECNIS Toric II (ZCU) intraocular lens during standard phacoemulsification cataract surgery.
干预措施: TECNIS Toric II (ZCU) (Device)
AcrySof IQ Toric
Participants randomized to this arm receive implantation of the AcrySof IQ Toric intraocular lens during standard phacoemulsification cataract surgery.
干预措施: AcrySof IQ Toric (Device)
AT TORBI 709M
Participants randomized to this arm receive implantation of the AT TORBI 709M intraocular lens during standard phacoemulsification cataract surgery.
干预措施: AT TORBI 709M (Device)
结局指标
主要结局
Absolute rotational misalignment of toric intraocular lens (IOL) measured in degrees
时间窗: Postoperative day 1, day 3, week 1, week 2, month 1, and month 3.
Absolute rotation of the implanted toric intraocular lens (IOL) relative to the intended axis, measured in degrees. Rotation will be quantified by registering postoperative retroillumination images to the end-of-surgery baseline frame using iris or scleral landmarks. The absolute rotation angle will be calculated for each follow-up visit.
次要结局
- Uncorrected and corrected distance visual acuity (UDVA and CDVA)(postoperatively on 1 day, 3 days, 1 week, 2 weeks, 1 month and 3 months)
- Postoperative residual refractive astigmatism measured in diopters(Postoperative day 1, day 3, week 1, week 2, month 1, and month 3.)
研究者
Jin Yang
Chief Physician
Eye & ENT Hospital of Fudan University