Effect of Capsular Tension Ring Implantation on Postoperative IOL Position in Retinitis Pigmentosa Patients With Cataract: a Single-center, Randomized, Self-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- IOL dencentration
研究概览
简要总结
This is a self-controlled randomized clinical trial to investigate the effect of capsular tension ring (CTR) implantation on intraocular lens (IOL) position in cataract patients with retinitis pigmentosa(RP). Each patient will receive CTR implantation in one eye, with the fellow eye serving as control. Postoperative outcomes, including visual acuity, IOL position, and postoperative complications will be compared between eyes.
详细描述
Patients with retinitis pigmentosa (RP) have a higher risk of developing cataracts, often accompanied by abnormalities such as zonular laxity and vitreous liquefaction, which increases the risk of intraocular lens (IOL) tilt, decentration, and capsular contraction after surgery. The capsular tension ring (CTR) can support the zonules and maintain the stability of the capsular bag, but its effect in RP patients remains controversial.
In this self-controlled clinical trial, we are going to recruit 88 RP patients scheduled for bilateral cataract surgery. Both eyes receive a monofocal DCB00 IOL, while only on eye receives an additional CTR. Follow up visits take place 1 week, 1 month, 3 months, 6 months, and 1 year postoperatively. At the follow up visits, IOL decentration and tilt (determined by anterior segment SS-OCT Casia 2), visual acuity, and postoperative complications will be compared intraindividually at different timepoints.
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
- Single (Outcomes Assessor)
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
- •Age ≥ 18 years.
- •Clinical diagnosis of retinitis pigmentosa (RP).
- •Bilateral cataract meeting the indications for IOL implantation.
- •Willingness to participate in the study and provision of signed informed consent.
排除标准
- •History of intraocular surgery.
- •Severe zonular weakness (e.g., zonular dialysis >90°, lens subluxation/dislocation)
- •Other ocular comorbidity: such as pseudoexfoliation syndrome, ocular trauma, corneal dystrophies, uveitis, etc.
- •Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.
研究组 & 干预措施
Treatment Group: IOL Plus CTR implantation
Patients will undergo phacoemulsification combined with IOL and CTR implantation
干预措施: CTR implantation (Procedure)
Control Group: IOL implantation Only
Patients will undergo phacoemulsification combined with IOL implantation. All patients undergo uneventful phacoemulsification by a 2.2 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL (J&J Tecnis DCB00) is implanted in the capsular bag.
结局指标
主要结局
IOL dencentration
时间窗: 3 months after surgery
Measured by anterior segment OCT (CASIA2)
次要结局
- IOL dencentration(Baseline (before surgery), 1 week, 1 month, 6 months, 1 year after surgery)
- Postoperative complications(1 week, 1 month, 3 months, 6 months, 1 year after surgery)
- IOL tilt(Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery)
- BCVA(Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery)