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.
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.
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.
Parallel
Transscleral Suture-Fixated Intraocular Lens Implantation (Suture Needle Insertion at 2.5 mm Posterior to the Limbus)
Procedure/SurgeryParticipants 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.
Refractive Predictive Error of Patients at the 3-month Postoperative Follow-up
Case report form records
Uncorrected Visual Acuity (UCVA) and Best-Corrected Visual Acuity (BCVA) of Patients at the 3-Month Postoperative Follow-up
Measured using the EDTRS chart
lOL Tilt and Decentration in Patients at the 3-Month Postoperative Follow-up
Measured by the Casia 2 AS-OCT Instrument
Corneal Endothelial Cell Count of Patients at the 3-Month Postoperative Follow-up
Measured using a corneal endothelial microscope
Incidence of Postoperative Complications at the 3-Month Postoperative Follow-up
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