NCT07407049

Comparison of Early Postoperative Visual Acuity Between Intracapsular and Supracapsular Phacoemulsification: A Randomized Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Cataracts are the leading cause of blindness worldwide, and phacoemulsification combined with intraocular lens implantation has become the most mainstream surgical approach. With advancements in surgical techniques and equipment, this procedure has evolved from a simple vision-restoring surgery into the era of refractive surgery. Patients now have higher expectations for postoperative visual quality, particularly the recovery of early vision, which directly impacts their satisfaction. Intraoperative surgical details have a direct influence on postoperative visual acuity. Thanks to intraoperative optical coherence tomography (iOCT) technology, surgeons have gradually recognized that factors such as surgical incisions and intraoperative anterior chamber collapse can affect the survival of corneal endothelial cells after surgery, which is directly related to early postoperative vision and patient satisfaction. Swept-source intraoperative OCT (SS-iOCT) has further improved imaging range and clarity, helping us discover that the depth of intraoperative ultrasound energy use (such as cumulative dissipated energy) correlates with postoperative corneal endothelial cell loss. This suggests that compared to performing phacoemulsification at the capsular opening plane or in the anterior chamber, intracapsular phacoemulsification may reduce postoperative corneal endothelial cell loss, potentially leading to better early postoperative vision, which is crucial for patient satisfaction. However, evidence is still lacking. Therefore, this study aims to compare the effects of intracapsular versus extracapsular phacoemulsification on early postoperative vision, as well as long-term visual acuity, corneal endothelial cells, corneal changes, and the incidence of intraoperative and postoperative complications.

Conditions

• Cataract

Interventions

Type	Name	Description
PROCEDURE	Supracapsular Phacoemulsification	During phacoemulsification, real-time imaging of the anterior segment was performed using SS-iOCT (Tupai, China), but the surgeon was not able to view the images. The surgeon was instructed to proceed with phacoemulsification as per routine, using phaco energy (i.e., level 3). All other surgical steps were identical to conventional surgery.
PROCEDURE	Intracapsular Phacoemulsification	During phacoemulsification, real-time imaging of the anterior segment was performed using SS-iOCT (Tupai, China). The surgeon was required to confirm under SS-iOCT guidance that the phaco tip was located within the capsular bag (as judged by two observers not involved in the surgery) before applying phaco energy (i.e., level 3). All other surgical steps were identical to conventional surgery.

Timeline

• Start date: 2026-02-24
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

1 site across 1 country: China