Intraocular Lens-shell Technique in Phacoemulsification

Not Applicable

Completed

• Conditions: Cataract; Pseudoaphakia

• Registration Number: NCT02138123
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-14
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-06
• Last Update Posted: 2014-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Aged 50 years or above
• Dense cataract cases were defined as eyes in which the nuclear color was graded IV or V according to the Lens Opacities Classification System III (LOCS III). Special attention was paid in selecting cases without apparent posterior cortical layer.
• No central corneal opacification
• Pupil diameter >= 7 mm after full pharmacological dilation in preoperative assessment
• A preoperative central endothelial cell count of >= 1500 cells/mm2.

Exclusion Criteria

• Participants with previous intraocular surgery
• Abnormal lens zonules
• Glaucoma
• High myopia (>-6.0 Diopters)
• Pseudoexfoliation
• Uveitis
• Diabetes mellitus
• Those who were not able to come for follow-up visits.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Central corneal endothelial cell loss	one month	Central corneal endothelial cell loss was calculated by subtracting postoperative corneal endothelial cell density from the preoperative baseline level.

Secondary Outcome Measures

Name	Time	Method
central cornea thickness	one month	The temporal corneal thickness and central corneal thickness were measured using the manual measurement scale in the scanning pictures of anterior segment optical coherence tomography preoperatively and at each postoperative visit.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center,Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China