跳至主要内容
临床试验/NCT07446829
NCT07446829尚未招募不适用

Effect of Different Needle Insertion Positions on the Clinical Outcomes of YAMANE Technique for Intrascleral Intraocular Lens Fixation: a Randomized Controlled Trial

Zhongshan Ophthalmic Center, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2026年2月28日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
54
试验地点
1
主要终点
Refractive Predictive Error of Patients at the 3-month Postoperative Follow-up

研究概览

简要总结

This is a single-blind, single-center, parallel-group randomized controlled trial with the following objectives: First, researchers aim to compare the clinical efficacy of 2mm and 2.5mm post-limbal needle insertion in YAMANE technique for patients with congenital ectopia lentis. Second, the goal is to investigate the mean absolute refractive prediction error, IOL tilt and decentration, uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), and corneal endothelial cell count at 3 months postoperatively. Third, it intends to explore the incidence of postoperative complications of the two needle insertion positions in this specific surgical method. Finally, this study aims to provide evidence for ophthalmic clinical practice, explore the optimal needle insertion point, and offer more precise and safe surgical plans for patients requiring sutureless transscleral IOL fixation.

详细描述

For patients with insufficient capsular bag support caused by congenital developmental abnormalities, trauma, or other etiologies and who meet the indications for intraocular lens (IOL) implantation, IOL suspension surgery is the primary surgical procedure. As an innovative IOL suspension technique, the YAMANE technique has been widely favored by ophthalmologists. Due to its sutureless feature, this technique reduces the risk of postoperative complications such as infection and hypotony, while greatly simplifying surgical procedures.

In previous studies on the YAMANE technique, needle insertion sites were commonly set at 2 mm and 2.5 mm posterior to the cornea limbus. Among them, the 2.5 mm post-limbal insertion point was associated with a smaller mean absolute refractive prediction error and better clinical outcomes. Although a few studies have evaluated the clinical efficacy of the YAMANE technique, no study has systematically compared its clinical outcomes between different needle insertion positions. Considering that differences in the insertion point may directly affect postoperative refractive status, IOL stability, and visual outcomes, evaluating the impact of different insertion sites on surgical results is critical for optimizing surgical strategies and improving therapeutic efficacy.

In this randomized controlled trial, the investigators will systematically investigate the clinical efficacy of needle insertion at 2 mm versus 2.5 mm posterior to the cornea limbus in the YAMANE technique. Through this study, the investigators aim to provide evidence for ophthalmic clinical practice, explore the optimal needle insertion point, and offer a more precise and safe surgical plan for patients undergoing the YAMANE technique.

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)

盲法说明

This study adopts a single-blind design, with no blinding of investigators but with blinding of participants and assessors implemented. To reduce bias under the single-blind condition, trial-related personnel involved in participant screening remain blinded, and clinical staff conducting routine ophthalmological examinations as well as data analysts are kept blinded to the treatment allocation.

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 4-18 years (regardless of gender) who meet the indications for YAMANE technique.
  • Patients who can complete a follow-up period of at least 3 months after surgery.
  • Patients or their legal guardians who provide informed consent to participate in this study.

排除标准

  • Patients with concurent secondary qlaucoma, retinal detachment, strabismus, or other relevant ocular complications (excluding refractive errors).
  • Patients participating in other trials that may affect the results of this study.

研究组 & 干预措施

intervention group(suture needle insertion at 2.5 mm posterior to the cornea limbus)

Experimental

Participants in the intervention group should complete a comprehensive ophthalmic examination at baseline, undergo needle insertion 2.5mm post-limbal during surgery,and receive routine follow-up at 1 week, 1 month, and 3 months postoperatively.

干预措施: YAMANE technique(Suture Needle Insertion at 2.5 mm Posterior to the Limbus) (Procedure)

compare group(suture needle insertion at 2 mm posterior to the cornea limbus)

No Intervention

Participants in the intervention group should complete a comprehensive ophthalmic examination at baseline, undergo needle insertion 2mm post-limbal during surgery,and receive routine follow-up at 1 week, 1 month, and 3 months postoperatively

结局指标

主要结局

Refractive Predictive Error of Patients at the 3-month Postoperative Follow-up

时间窗: 3-month Postoperative Follow-up

Case report form records

次要结局

  • Corneal Endothelial Cell Count of Patients at the 3-Month Postoperative Follow-up(3-month Postoperative Follow-up)
  • Incidence of Postoperative Complications at the 3-Month Postoperative Follow-up(3-month Postoperative Follow-up)
  • Uncorrected Visual Acuity (UCVA) of Patients at the 3-Month Postoperative Follow-up(3-month Postoperative Follow-up)
  • Best-Corrected Visual Acuity (BCVA) of Patients at the 3-Month Postoperative Follow-up(3-month Postoperative Follow-up)
  • IOL Tilt in Patients at the 3-Month Postoperative Follow-up(3-month Postoperative Follow-up)
  • IOL Decentration in Patients at the 3-Month Postoperative Follow-up(3-month Postoperative Follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guangming Jin

Associate Chief Physician, Cataract Department

Zhongshan Ophthalmic Center, Sun Yat-sen University

研究点 (1)

Loading locations...

相似试验