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

NCT07446829 | Not Yet Recruiting DMC

• 1 other identifier: 2025KYPJ137
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Ectopia Lentis

Outcome Measures

Primary Outcomes (1)

• Refractive Predictive Error of Patients at the 3-month Postoperative Follow-up

  Case report form records

  3-month Postoperative Follow-up

Secondary Outcomes (6)

• Uncorrected Visual Acuity (UCVA) of Patients at the 3-Month Postoperative Follow-up

  3-month Postoperative Follow-up

• Best-Corrected Visual Acuity (BCVA) of Patients at the 3-Month Postoperative Follow-up

  3-month Postoperative Follow-up

• IOL Tilt in Patients at the 3-Month Postoperative Follow-up

  3-month Postoperative Follow-up

• IOL Decentration in Patients at the 3-Month Postoperative Follow-up

  3-month Postoperative Follow-up

• Corneal Endothelial Cell Count of Patients at the 3-Month Postoperative Follow-up

  3-month Postoperative Follow-up

Study Arms (2)

intervention group(suture needle insertion at 2.5 mm posterior to the cornea limbus)

EXPERIMENTAL

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)

compare group(suture needle insertion at 2 mm posterior to the cornea limbus)

NO INTERVENTION

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

Interventions

YAMANE technique(Suture Needle Insertion at 2.5 mm Posterior to the Limbus) PROCEDURE

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.

intervention group(suture needle insertion at 2.5 mm posterior to the cornea limbus)

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 4-18 years (regardless of gender) who meet the indications for YAMANE technique.
• Patients who can complete a follow-up period of at least 3 months after surgery.
• Patients or their legal guardians who provide informed consent to participate in this study.

You may not qualify if:

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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (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 and Visual Science

Guangdong, Province, 510060, China

Location

Related Publications (10)

• Qu Y, Duan P, Huo S, Li F, Li J. Sutured Intrascleral Posterior Chamber Intraocular Lens Fixation with Ciliary Sulcus Location Guided by Ultrasonic Biological Microscopy: A Retrospective Analysis of Anatomical and Refractive Outcome. J Ophthalmol. 2020 Jun 4;2020:5843410. doi: 10.1155/2020/5843410. eCollection 2020.

  PMID: 32587761 RESULT

• Rocke JR, McGuinness MB, Atkins WK, Fry LE, Kane JX, Fabinyi DCA, Yeoh J, Chiu D, Essex MBiostat RW, Roufail E, Sheridan AM, Allen PJ, Edwards TL. Refractive Outcomes of the Yamane Flanged Intrascleral Haptic Fixation Technique. Ophthalmology. 2020 Oct;127(10):1429-1431. doi: 10.1016/j.ophtha.2020.03.032. Epub 2020 Apr 3. No abstract available.

  PMID: 32359838 RESULT

• Blagun N, Krix-Jachym K, Rekas M. Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and the Yamane Technique. Ophthalmol Ther. 2024 Jul;13(7):1955-1966. doi: 10.1007/s40123-024-00962-7. Epub 2024 May 21.

  PMID: 38771460 RESULT

• Trivedi V, Lee S, Lee PSY, Me R, You Q, Im J, Ross B, Tran DV, Le KH, Malbin B, Lin X. Comparative Analysis of Effective Lens Position and Refractive Outcomes in Scleral-Fixated versus Intracapsular Intraocular Lenses. Clin Ophthalmol. 2024 Dec 25;18:3949-3955. doi: 10.2147/OPTH.S486044. eCollection 2024.

  PMID: 39737363 RESULT

• Erakgun T, Gobeka HH. The novel haptic-twist method for a sutureless double-needle intrascleral haptic fixation technique. Int Ophthalmol. 2021 Sep;41(9):3013-3020. doi: 10.1007/s10792-021-01862-6. Epub 2021 May 20.

  PMID: 34014460 RESULT

• Schranz M, Reumuller A, Kostolna K, Novotny C, Schartmuller D, Abela-Formanek C. Refractive outcome and lens power calculation after intrascleral intraocular lens fixation: a comparison of three-piece and one-piece intrascleral fixation technique. Eye Vis (Lond). 2023 Jun 9;10(1):29. doi: 10.1186/s40662-023-00341-6.

  PMID: 37291668 RESULT

• Limon U, Akcay BIS. A novel Yamane technique modification: Reverse intraocular lens implantation for simplifying trailing haptic insertion. Indian J Ophthalmol. 2023 May;71(5):2244-2246. doi: 10.4103/IJO.IJO_3158_22.

  PMID: 37202960 RESULT

• Sahin Vural G, Guven YZ, Karahan E, Zengin MO. Long term outcomes of Yamane technique in various indications. Eur J Ophthalmol. 2023 Nov;33(6):2210-2216. doi: 10.1177/11206721231167198. Epub 2023 Apr 10.

  PMID: 37038337 RESULT

• Shasha R. Yamane intrascleral haptic fixation, white-to-white distance, and the temporal approach. J Cataract Refract Surg. 2023 May 1;49(5):543-544. doi: 10.1097/j.jcrs.0000000000001172. No abstract available.

  PMID: 37088937 RESULT

• Tang Y, Gao Y, Chu Y, Liu Y, Han Q. Modified Yamane technique with a 26-gauge needle: single corneal incision and simplified haptic insertion. J Cataract Refract Surg. 2022 Jan 1;48(1):e1-e4. doi: 10.1097/j.jcrs.0000000000000816.

  PMID: 34524208 RESULT

Study Officials

• 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

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangming Jin

CONTACT

+86 13560035613; jinguangming@gzzoc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study adopts a single-blind design, with no blinding of investigators but with blinding of participants and assessors implemented. To reduce bias under the single-blind condition, trial-related personnel involved in participant screening remain blinded, and clinical staff conducting routine ophthalmological examinations as well as data analysts are kept blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Cataract Department

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE

Locations

CN (1)