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NCT07252349
NA

Influence of Different Needle Insertion Positions on the Clinical Efficacy of Suture-Fixated Transscleral IOL Implantation Without Knots

Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

View on ClinicalTrials.gov

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 sutureless transscleral IOL fixation 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.

Official title: Influence of Different Needle Insertion Positions on the Clinical Efficacy of Suture-Fixated Transscleral IOL Implantation Without Knots: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

4 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2025-12-25

Completion Date

2027-08-31

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

PROCEDURE

Transscleral Suture-Fixated Intraocular Lens Implantation (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.

Locations (1)

Clinical Research Center for Ocular Diseases, State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology andVisual Science, Guangzhou, Guangdong

Guangdong, Province, China