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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Refractive Predictive Error of Patients at the 3-month Postoperative Follow-up — 3-month Postoperative Follow-up
  Case report form records

Trial sites (1)

More Zhongshan Ophthalmic Center, Sun Yat-sen University trials in China

Other trials for the same condition