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

March 2, 2026 updated by: Guangming Jin, Zhongshan Ophthalmic Center, Sun Yat-sen University

Effect of Different Needle Insertion Positions on the Clinical Outcomes of YAMANE Technique for Intrascleral Intraocular Lens Fixation: 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 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

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 and Visual Science
        • 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 YAMANE technique.
  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 (excluding refractive 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(suture needle insertion at 2.5 mm posterior to the cornea 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.
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.
No Intervention: compare group(suture needle insertion at 2 mm posterior to the cornea limbus)
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
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
Uncorrected Visual Acuity (UCVA) 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
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
IOL Tilt in Patients at the 3-Month Postoperative Follow-up
Time Frame: 3-month Postoperative Follow-up
by the Casia 2 AS-OCT Instrument
3-month Postoperative Follow-up
IOL Decentration in Patients at the 3-Month Postoperative Follow-up
Time Frame: 3-month Postoperative Follow-up
by the Casia 2 AS-OCT Instrument
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 ResearchCenter for Ocular Diseases, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science,Guangzhou, Guangdong
  • Principal Investigator: Guangming Jin, Guangdong Provincial Clinical Research Center for Ocular Diseases, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science,Guangzhou, 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)

February 28, 2026

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2025KYPJ137

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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