Influence of Different Needle Insertion Positions on the Clinical Efficacy of Suture-Fixated Transscleral IOL Implantation Without Knots
NCT ID: NCT07252349
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
54 participants
INTERVENTIONAL
2025-12-25
2027-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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intervention group
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.
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.
compare group
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. Patients participating in other trials that may affect the results of this study.
4 Years
18 Years
ALL
No
Sponsors
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Zhongshan Ophthalmic Center, Sun Yat-sen University
OTHER
Responsible Party
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Guangming Jin
Associate Chief Physician, Cataract Department
Principal Investigators
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Danying Zheng
Role: STUDY_CHAIR
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
Guangming Jin
Role: PRINCIPAL_INVESTIGATOR
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
Locations
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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, China
Countries
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Central Contacts
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Facility Contacts
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Guangming Jin
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2025KYPJ136
Identifier Type: -
Identifier Source: org_study_id