Effect of Different Needle Insertion Positions on the Clinical Outcomes of YAMANE Technique
Starting soon · Not applicable
Conditions studied: Congenital Ectopia Lentis
In brief
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.
Key facts
- Study ID
- NCT07446829
- Run by
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- People needed
- 54
- Starts
- 2026-02-28
- Expected to finish
- 2027-08-30
- Last updated by the study team
- 2026-03-04
Who can join
Age: 4 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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, China
Full record on ClinicalTrials.gov
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