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

NCT07252349 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-12-18

No results posted yet for this 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 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.

Conditions

  • Congenital Ectopia Lentis

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.

Sponsors & Collaborators

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Danying Zheng · Guangdong Provincial Clinical Research Center for Ocular Diseases, State Key Laboratory of Ophthalmology, ZhongshanOphthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual SodGuangzhou, Guangdong

  • Guangming Jin · Guangdong Provincial Clinical Research Center for Ocular Diseases, State Key Laboratory of Ophthalmology, ZhongshanOphthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual ScienceGuangzhou, Guangdong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-25
Primary Completion
2027-02-03
Completion
2027-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07252349 on ClinicalTrials.gov