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

Official title

Effect of Different Needle Insertion Positions on the Clinical Outcomes of YAMANE Technique for Intrascleral Intraocular Lens Fixation: a Randomized Controlled Trial

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Refractive Predictive Error of Patients at the 3-month Postoperative Follow-up [Time frame: 3-month Postoperative Follow-up]

Secondary outcome measures (6)

• Uncorrected Visual Acuity (UCVA) of Patients at the 3-Month Postoperative Follow-up [Time frame: 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]
• IOL Tilt in Patients at the 3-Month Postoperative Follow-up [Time frame: 3-month Postoperative Follow-up]
• IOL Decentration in Patients at the 3-Month Postoperative Follow-up [Time frame: 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]
• Incidence of Postoperative Complications at the 3-Month Postoperative Follow-up [Time frame: 3-month Postoperative Follow-up]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Clinical Research Center for Ocular Diseases, State Key Laboratory of Ophthalmology, Zhong — Guangdong

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07446829 · 2025KYPJ137

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗