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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

54 Participants
are divided into 2 treatment groups