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

NCT07252349 | Not Yet Recruiting DMC

• 1 other identifier: 2025KYPJ136
• 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 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.

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 (4)

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

  3-month Postoperative Follow-up

• lOL Tilt and 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

• Incidence of Postoperative Complications at the 3-Month Postoperative Follow-up

  3-month Postoperative Follow-up

Study Arms (2)

intervention group

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: Transscleral Suture-Fixated Intraocular Lens Implantation (Suture Needle Insertion at 2.5 mm Posterior to the Limbus)

compare group

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

Transscleral Suture-Fixated Intraocular Lens Implantation (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

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 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.

You may not qualify if:

• 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.

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 andVisual Science, Guangzhou, Guangdong

Guangdong, Province, 510060, China

Location

Related Publications (13)

• 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

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Lee KRCK, Fung AT. Four-point subconjunctival scleral fixation technique using Gore-Tex suture. Clin Exp Ophthalmol. 2021 May;49(4):397-399. doi: 10.1111/ceo.13938. Epub 2021 May 11. No abstract available.

  PMID: 33913234 RESULT

• Dogan L, Edhem Yilmaz I. Quaternary Knot Technique: Suture Knot Burial without Scleral Flap or Incision for Trans-scleral Fixation. J Ophthalmic Vis Res. 2023 Jul 28;18(3):342-347. doi: 10.18502/jovr.v18i3.13784. eCollection 2023 Jul-Sep.

  PMID: 37600913 RESULT

• Czajka MP, Frajdenberg A, Johansson B. Technique for Sutured Scleral Fixation of One-Piece Hydrophobic Acrylic Intraocular Lenses Dislocated Into the Vitreous. Retina. 2023 Aug 1;43(8):1413-1416. doi: 10.1097/IAE.0000000000003008.

  PMID: 33149099 RESULT

• Byun Z, Kim DI, Kong M. LONG-TERM ANALYSIS OF INTRASCLERAL FIXATION OF INTRAOCULAR LENS: Trocar-Cannula-Based Sutureless Intrascleral Fixation Versus Sutured Scleral Fixation. Retina. 2023 May 1;43(5):815-822. doi: 10.1097/IAE.0000000000003721.

  PMID: 36728892 RESULT

• Choi HJ, Kwon OW, Byeon SH, Song JH. Clinical outcomes of combined pars plana vitrectomy and scleral fixation of the intraocular lens with a suspension bridge method in eyes with aphakia or insufficient capsular support. Acta Ophthalmol. 2021 Nov;99(7):e1006-e1012. doi: 10.1111/aos.14758. Epub 2021 Jan 9.

  PMID: 33421312 RESULT

Study Officials

• 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

  STUDY CHAIR

• 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

  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: November 18, 2025
• First Posted: November 26, 2025
• Study Start: December 25, 2025
• Primary Completion (Estimated): February 3, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-10

Data Sharing

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

Locations

CN (1)