NCT07446829

Effect of Different Needle Insertion Positions on the Clinical Outcomes of YAMANE Technique

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Congenital Ectopia Lentis

Interventions

Type	Name	Description
PROCEDURE	YAMANE technique(Suture Needle Insertion at 2.5 mm Posterior to the Limbus)	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.

Timeline

• Start date: 2026-02-28
• Primary completion: 2027-08-30
• Completion: 2027-08-30
• First posted: 2026-03-03
• Last updated: 2026-03-04

Locations

1 site across 1 country: China