A Prospective Randomized Controlled Trial of Toric Intraocular Lens Implantation in Pediatric Cataractous Eyes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Uncorrected (UCDVA) and corrected (CDVA) distance visual acuity
研究概览
简要总结
To evaluate the visual and refractive outcomes after an intraocular lens (IOL) implantation in pediatric eyes with cataract and preexisting corneal astigmatism
详细描述
This single-center, single-blinded, prospective, randomized controlled trial was performed at two sites of Kazakh Eye Research Institute.
Children with pediatric cataract and corneal astigmatism were included and randomized to two groups for pediatric cataract surgery with toric and non-toric intraocular lens (IOL) implantation. The uncorrected and corrected distance visual acuity, near visual acuity, keratometry data, and residual astigmatism were evaluated.
The purpose of this study is to evaluate the visual and refractive outcomes after a toric IOL implantation in pediatric eyes with cataract and preexisting corneal astigmatism.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Visually significant cataract;
- •Corneal astigmatism more than 1.25 diopters;
- •Children aged ≥ 6 years and < 18 years.
排除标准
- •Patients with a corneal diameter less than 9 mm;
- •Presence of corneal scarring;
- •Irregular astigmatism;
- •Intraocular pressure more than 25 mm Hg;
- •Active inflammatory process of the eyeball or signs of a previous episode of inflammation;
- •Traumatic, subluxated, or complicated cataract;
- •Persistent Fetal Vasculature;
- •Diseases of the optic nerve or macula that may limit visual potential;
- •History of previous intraocular surgeries;
- •Performing posterior capsulorhexis intraoperatively.
研究组 & 干预措施
Toric
A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx
干预措施: congenital/pediatric cataract surgery (Procedure)
Toric
A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx
干预措施: Toric IOLs (Device)
Non-toric
A folding hydrophobic acrylic intraocular lens (IOL) AcrySof IQ SN60WF and Clareon SY60WF
干预措施: congenital/pediatric cataract surgery (Procedure)
Non-toric
A folding hydrophobic acrylic intraocular lens (IOL) AcrySof IQ SN60WF and Clareon SY60WF
干预措施: Non-Toric IOLs (Device)
结局指标
主要结局
Uncorrected (UCDVA) and corrected (CDVA) distance visual acuity
时间窗: recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)
measured using the Lea symbol visual acuity chart or the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart according to the patient\&amp;#39;s age
Uncorrected (UCNVA) and corrected (CNVA) near visual acuity
时间窗: recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)
measured using the Lea symbol visual acuity chart or the ETDRS chart for near according to the patient\&#39;s age
Refraction measurements
时间窗: recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)
obtained with KR-1W Wavefront Analyzer
次要结局
- Keratometry measurements(recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year))
研究者
Kairat Ruslanuly
a researcher, a vitreoretinal surgeon
Kazakh Eye Research Institute