Toric Intraocular Lens (IOL) Implantation Compared to Incisional Surgery to Correct Corneal Astigmatism as Part of Cataract Surgery - A Randomised Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Astigmatism reduction effect of toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions.
研究概览
简要总结
The purpose of the study is to compare the astigmatism reducing effect of a toric intraocular lens (IOL) (model MX60T - Bausch & Lomb) with that of limbal relaxing incisional surgery combined with a non toric IOL (model MX60 - Bausch & Lomb) in patients with corneal astigmatism between 1.0 and 1.5 diopters and also the effect of cylinder reduction on patient's quality of vision.
详细描述
This is a randomised controlled trial with intra-patient comparison (bilateral study) in which study patients will be randomized by a medical statistician to the implantation of the toric intraocular lens (IOL) (model MX60T, Bausch & Lomb) in one eye and the non-toric IOL model MX60 plus LRI in the fellow eye.
During pre-operative examination, the patient will undergo:
- An ophthalmic examination including slit lamp biomicroscopy and retinal examination;
- Uncorrected and best-corrected visual acuity (UCVA and BCVA): monocular and binocular;
- Optical biometry with IOLMaster (Carl Zeiss Meditec);
- Orbscan corneal topography (Bausch and Lomb Orbscan IIz Corneal Analysis System);
- Quality of Vision (QoV) questionnaire score). It is a validated, Rasch-adjusted questionnaire in which patients are asked to rate 10 dysphotopsia items illustrated by standard photographs, scoring each item (0, 1, 2, 3) in relation to how frequent, severe, and bothersome their symptoms are (30 items in total).
- Catquest 9-SF cataract visual disability questionnaire. It is a Rasch-adjusted cataract visual disability questionnaire that asks patients to rate difficulty with a range of vision-related daily activities.
The appropriate cylinder power of the MX60T toric-IOL as well of its axis of implantation will be calculated with the calculator provided by the manufacturer Bausch + Lomb (https://trulign.toriccalculator.com).
Subsequently, the patient will undergo cataract surgery with IOL implantation under local anaesthesia.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bilateral cataract.
- •Age 21 and older.
- •Written informed consent to sequential bilateral surgery and participation in the study.
- •Preoperative pupil size greater than or equal to 5.0 mm in the study eye.
- •IOL power as predicted by biometry ranging from 6.0 D to 30.0 D in both eyes.
- •Regular corneal astigmatism according to Orbscan topography.
- •Postoperative corneal astigmatism between 0.90 D and 1.40 D in both eyes, as predicted by the Bausch + Lomb Toric Calculator (https://envista.toriccalculator.com).
排除标准
- •Ocular comorbidity (corneal scars, amblyopia, retina, or optic nerve disease) that may reduce postoperative CDVA
- •Reduced zonular or capsular stability (e.g. Marfan syndrome, previous eye trauma)
- •Irregular corneal astigmatism on Orbscan topography
研究组 & 干预措施
Toric intraocular MX60T lens
one eye will receive toric MX60T lens
干预措施: Toric intraocular MX60T lens (Device)
Standard MX60 plus corneal incisions
the other eye will receive standard MX60 lens with corneal incisions
干预措施: Standard MX60 plus corneal incisions (Other)
结局指标
主要结局
Astigmatism reduction effect of toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions.
时间窗: 6 months and 12 months
Astigmatism reduction will be evaluated with optical biometry, corneal topography
Astigmatism reduction effect of toric intraocular lens (IOL) versus non-toric IOL
时间窗: 6 months and 12 months
Astigmatism reduction will be evaluated with manifest refraction, autorefraction
次要结局
- Visual disability(6 months and 12 months)
- Best-spectacle corrected visual acuity after toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions.(6 months and 12 months)
- Quality of Vision(6 months and 12 months)
- Overall satisfaction(6 months and 12 months)
- Dysphotopsia(6 months and 12 months)
- Unaided visual acuity after toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions.(6 months and 12 months)