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

December 11, 2025 updated by: Guangming Jin, Zhongshan Ophthalmic Center, Sun Yat-sen University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a professional translation conforming to medical academic writing standards (with unified key terms and specified abbreviation as required):

For patients with insufficient capsular bag support due to congenital developmental abnormalities, trauma, or other reasons, who have indications for intraocular lens (IOL) implantation, IOL suspension surgery is the main surgical method. Sutureless transscleral IOL fixation is one of the commonly used IOL suspension surgeries currently. Compared with traditional transscleral suture fixation, sutureless transscleral IOL fixation can effectively reduce suture-related complications while ensuring safety and effectiveness, with higher surgical safety.

In transscleral IOL fixation, previous studies have commonly used 2mm and 2.5mm post-limbal positions as needle insertion sites. The 2.5mm post-limbal needle insertion point has a smaller mean absolute refractive prediction error and better clinical efficacy postoperatively. As an IOL suspension surgery, differences in needle insertion positions may affect postoperative refractive status, IOL stability, visual outcomes, and other parameters. Although existing literature has evaluated the overall clinical efficacy and safety of sutureless transscleral IOL fixation, to date, no study has systematically compared the clinical efficacy of this commonly used IOL suspension surgery at different needle insertion positions. Therefore, evaluating the impact of different needle insertion positions on surgical outcomes is crucial for optimizing surgical strategies and improving treatment precision.

In this randomized controlled trial, the investigators will systematically investigate the clinical efficacy of 2mm and 2.5mm post-limbal needle insertion points in sutureless transscleral IOL fixation. Through this study, the investigators aim 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.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Province
      • Guangdong, Province, China, 510060
        • 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
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients aged 4-18 years (regardless of gender) who meet the indications for transscleral suture-fixated intraocular lens implantation
  2. Patients who can complete a follow-up period of at least 3 months after surgery;
  3. Patients or their legal guardians who provide informed consent to participate in this study.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
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.
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.
No Intervention: compare group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Refractive Predictive Error of Patients at the 3-month Postoperative Follow-up
Time Frame: 3-month Postoperative Follow-up
Case report form records
3-month Postoperative Follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uncorrected Visual Acuity (UCVA) and Best-Corrected Visual Acuity (BCVA) of Patients at the 3-Month Postoperative Follow-up
Time Frame: 3-month Postoperative Follow-up
Measured using the EDTRS chart
3-month Postoperative Follow-up
lOL Tilt and Decentration in Patients at the 3-Month Postoperative Follow-up
Time Frame: 3-month Postoperative Follow-up
Measured by the Casia 2 AS-OCT Instrument
3-month Postoperative Follow-up
Corneal Endothelial Cell Count of Patients at the 3-Month Postoperative Follow-up
Time Frame: 3-month Postoperative Follow-up
Measured using a corneal endothelial microscope
3-month Postoperative Follow-up
Incidence of Postoperative Complications at the 3-Month Postoperative Follow-up
Time Frame: 3-month Postoperative Follow-up
3-month Postoperative Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

  • Study Chair: 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
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 25, 2025

Primary Completion (Estimated)

February 3, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Estimated)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025KYPJ136

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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