The Role of Capsular Tension Rings in Intraocular Lens Stability in High Myopia Cataract Patients: A Prospective Self-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Tilt and Decentration
研究概览
简要总结
Study Purpose:
This prospective, self-controlled clinical study aims to evaluate the impact of capsular tension rings (CTR) on intraocular lens (IOL) stability in high myopia patients undergoing bilateral cataract surgery. Each patient will receive CTR implantation in one eye, with the fellow eye serving as control. Postoperative outcomes, including visual acuity, refraction, IOL positioning, and visual quality, will be compared between eyes to assess the effectiveness of CTR.
Study Methods:
Eligible participants (axial length ≥ 26.0 mm) will undergo femtosecond-assisted phacoemulsification with identical IOLs implanted in both eyes. One eye will be randomly assigned to receive a CTR. All surgeries will be performed by the same surgeon. Follow-up will be conducted at 1 day, 1 week, 1 month, 3 months, and 6 months postoperatively. Assessments will include UCVA, BCVA, refractive error, anterior segment OCT, IOL decentration and tilt, and visual quality (iTrace).
Sample Size and Population:
A total of 60 patients (120 eyes) will be enrolled. Inclusion criteria include age ≥ 18 years and bilateral cataracts with high myopia. Exclusion criteria include other ocular diseases, history of severe ocular trauma, or poor visual potential. Patients will be stratified by axial length into three groups: ≤28 mm, 28-30 mm, and >30 mm.
Study Procedure:
After informed consent and baseline examinations (including ocular biometry and imaging), patients will undergo surgery and be followed at specified intervals. All data will be managed securely. Comparative analysis between CTR and non-CTR eyes will be performed to evaluate the effect of CTR on IOL stability and visual outcomes in highly myopic cataract patients.
详细描述
Study Purpose:
This study aims to evaluate the effect of capsular tension rings (CTR) on intraocular lens (IOL) stability in cataract patients with high myopia. Each patient will undergo cataract surgery in both eyes, with one eye receiving a CTR and the other eye not receiving a CTR, using the same IOL model in both eyes. Postoperative visual quality and IOL stability will be compared between the two eyes. The study will analyze changes in postoperative visual acuity, refraction, ocular parameters, anterior segment morphology, and IOL positioning to assess the effect of CTR implantation on visual outcomes in highly myopic patients.
Study Methods:
This is a prospective, self-controlled clinical study involving cataract patients with high myopia (axial length ≥ 26.0 mm) scheduled for bilateral cataract surgery. Patients will undergo femtosecond-assisted phacoemulsification and IOL implantation in both eyes, with one eye randomly assigned to receive a CTR and the other not. All procedures will be performed by the same surgeon to ensure consistency. Postoperative follow-up visits will be scheduled at 1 day, 1 week, 1 month, 3 months, and 6 months. Evaluation indicators include uncorrected and best corrected visual acuity (UCVA, BCVA), refractive status, intraocular pressure, anterior segment morphology (anterior segment OCT), IOL decentration and tilt (using anterior segment images), and visual quality (iTrace).
Sample Size and Study Population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Diagnosed with bilateral age-related cataracts and scheduled for phacoemulsification with IOL implantation in both eyes.
- •High myopia in both eyes, defined as axial length (AL) ≥ 26.0 mm.
- •No significant difference in axial length between the two eyes (e.g., interocular AL difference < 1.0 mm).
- •Willingness and ability to undergo bilateral surgery within a short interval (e.g., within 1-2 weeks).
- •Able to provide informed consent and comply with the study protocol and follow-up visits.
排除标准
- •History of ocular trauma, surgery, or intraocular inflammation in either eye.
- •Presence of other ocular diseases that may affect visual outcomes, such as glaucoma, diabetic retinopathy, macular degeneration, or corneal opacity.
- •Evidence of zonular weakness, pseudoexfoliation, or significant phacodonesis preoperatively.
- •Severe dry eye or poor fixation that may interfere with postoperative imaging.
- •Systemic diseases affecting visual function (e.g., uncontrolled diabetes, neurologic disorders).
- •Participation in other clinical trials that may affect the study outcomes.
结局指标
主要结局
Tilt and Decentration
时间窗: Postoperative follow-up visits will be scheduled at 1 day, 1 week, 1 month, 3 months, and 6 months
measured by using anterior segment OCT
次要结局
- Anterior Capsular Contraction(1 day, 1 week, 1 month, 3 months, and 6 months postoperatively)
- visual acuity(1 day, 1 week, 1 month, 3 months, and 6 months postoperatively)
- Visual Quality(1 day, 1 week, 1 month, 3 months, and 6 months postoperatively)
研究者
Jin Yang
Chief Physician
Eye & ENT Hospital of Fudan University