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

Official title

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

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.

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.

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 (4)

• 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]
• lOL Tilt and 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 transscleral suture-fixated intraocular lens implantation
• 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 (excludingrefractive 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,Zhongs — 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
• Kim J, Lee PY, Park MS, Cho BJ, Kwon S. Comparison of outcomes between modified double-flanged sutureless scleral fixation and conventional sutured scleral fixation. Sci Rep. 2024 Jul 12;14(1):16111. doi: 10.1038/s41598-024-66762-y. PMID 38997328
• Yoon EG, Eom Y, Woo M, Jeon HS, Kim SJ, Song JS, Kim HM. Clinical Outcomes of Intrascleral Fixation of Intraocular Lens Compared to Ciliary Sulcus Implantation and Transscleral Fixation. Korean J Ophthalmol. 2023 Apr;37(2):128-136. doi: 10.3341/kjo.2022.0093. Epub 2023 Feb 9. PMID 36758538
• Dubinsky-Pertzov B, Mahler OS, Hecht I, Shemer A, Or L, Gazit I, Pras E, Einan-Lifshitz A. Accuracy of Intraocular Lens Calculation Formulas for the Four-Flanged Fixation Technique in Eyes With No Capsular Support. J Refract Surg. 2022 Oct;38(10):668-673. doi: 10.3928/1081597X-20220919-01. Epub 2022 Oct 1. PMID 36214349
• Leuzinger-Dias M, Lima-Fontes M, Rodrigues R, Oliveira-Ferreira C, Madeira C, Falcao-Reis F, Fernandes V, Rocha-Sousa A, Falcao M. Scleral Fixation of Akreos AO60 Intraocular Lens Using Gore-Tex Suture: An Eye on Visual Outcomes and Postoperative Complications. J Ophthalmol. 2021 Dec 20;2021:9349323. doi: 10.1155/2021/9349323. eCollection 2021. PMID 34966559
• Micheletti JM, Weber N, McCauley MB, Doe EA, Coffee RE, Caplan MB. Punch and rescue technique for scleral fixation of dislocated single-piece intraocular lenses. J Cataract Refract Surg. 2022 Feb 1;48(2):247-250. doi: 10.1097/j.jcrs.0000000000000845. PMID 34670946
• Zeilinger J, Kronschlager M, Schlatter A, Ruiss M, Bayer N, Findl O. Influence of Sutureless Scleral Fixation Techniques With 3-Piece Intraocular Lenses on Dislocation Force. Am J Ophthalmol. 2024 Aug;264:229-234. doi: 10.1016/j.ajo.2024.03.001. Epub 2024 Mar 10. PMID 38461946
• Shi J, Zong Y, Wu K, Jiang C. Simplified Technique for Correcting Intraocular Lens Decentration in Scleral-Sutured Fixation Surgery. Retina. 2025 Jan 17. doi: 10.1097/IAE.0000000000004401. Online ahead of print. PMID 39841916

Identifiers

NCT: NCT07252349 · 2025KYPJ136

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗