NCT02138123

Intraocular Lens-shell Technique in Phacoemulsification

Intraocular Lens-Shell Technique: An Adjustment of Surgical Procedure Makes Differences in Treating Dense Nucleus Cataract

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

In this study, the investigators introduce a surgical procedure called "IOL-shell technique" in the purpose of reduce complications of surgeries for dense cataract, and report a prospective randomized controlled study aiming at assessing efficacy and safety of the IOL-shell technique, which showed that the new procedure offered a safer way for hard cataract surgery over the conventional phacoemulsification procedure without compromise in efficacy.

Detailed description

A Prospective, randomized controlled study of 80 eyes with dense nucleus were enrolled. Patients were assigned to two groups: Group I: IOL was traditionally implanted after all nuclear fragments were completely removed, while in Group II, IOL was innovatively implanted in the bag before last residual nuclear fragment was removed. This novel adjusted surgical procedure, featured by using IOL as a protective barrier (named "IOL-shell technique"), not just as a refractive alternative, was conceptual different from the traditional step-by-step procedure. Clinical examinations including uncorrected visual acuity, central corneal thickness (CCT), temporal clear corneal thickness and the corneal endothelial cell density were carried out.

Conditions

• Cataract
• Pseudoaphakia

Interventions

Type	Name	Description
PROCEDURE	IOL-shell technique	Phacoemulsification was performed with the same device and handpieces, using the same phaco chop technique as in the conventional procedure group. What was different was that before the emulsification of the last nuclear fragment, cohesive viscoelastic material was injected below the nuclear fragment and a foldable IOL was implanted into the well inflated capsular bag posterior to the nuclear fragment. The remaining last piece of nuclear fragment was then emulsified and removed within the capsular bag.
PROCEDURE	Conventional procedure	In this procedure, a IOL was not implanted until all the nuclear fragments were removed.

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2014-05-14
• Last updated: 2014-06-09

Locations

1 site across 1 country: China