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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Refractive Predictive Error of Patients at the 3-month Postoperative Follow-up | Case report form records | 3-month Postoperative Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Visual Acuity (UCVA) of Patients at the 3-Month Postoperative Follow-up | Measured using the EDTRS chart | 3-month Postoperative Follow-up |
| Best-Corrected Visual Acuity (BCVA) of Patients at the 3-Month Postoperative Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guangming Jin | Contact | +86 13560035613 | jinguangming@gzzoc.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32587761 | Result | 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. | |
| 32359838 | Result |
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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.
|
Measured using the EDTRS chart
| 3-month Postoperative Follow-up |
| IOL Tilt in Patients at the 3-Month Postoperative Follow-up | by the Casia 2 AS-OCT Instrument | 3-month Postoperative Follow-up |
| IOL Decentration in Patients at the 3-Month Postoperative Follow-up | by the Casia 2 AS-OCT Instrument | 3-month Postoperative Follow-up |
| Corneal Endothelial Cell Count of Patients at the 3-Month Postoperative Follow-up | Measured using a corneal endothelial microscope | 3-month Postoperative Follow-up |
| Incidence of Postoperative Complications at the 3-Month Postoperative Follow-up | 3-month Postoperative Follow-up |
| Principal Investigator |
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| 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. |
| 38771460 | 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. |
| 39737363 | 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. |
| 34014460 | 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. |
| 37291668 | 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. |
| 37202960 | 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. |
| 37038337 | 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. |
| 37088937 | 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. |
| 34524208 | 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. |