Evaluate Capsular Apposition to Intraocular Lens

• Conditions: Capsule Opacification; Opacification of Intraocular Lens; Tissue Adhesions; Aphakia - Lens Capsule Present

• Registration Number: NCT01605812
• Lead Sponsor: Wenzhou Medical University

Brief Summary

In this study, the investigators examined the capsule-IOL interaction including anterior and posterior capsule adhesion, contact between posterior capsule and the posterior edge of intraocular lense (IOL), configuration of capsular bend and the incidence of posterior capsular opacity (PCO) between high myopia eyes and emmetropia eyes.

Detailed Description

150 eyes of 150 cataract patients scheduled for phacoemulsification surgery were recruited, of which 20 eyes were high myopia (AL \> 26mm) and 40 eyes were emmetropia (22 \< AL \< 25mm) as control group.High myopia eyes and 20 emmetropia eyes were implanted with the single-piece hydrophobic acrylic IOL (Acrysof IQ SN60WF, Alcon laboratories, Inc. IQ group). Another 20 emmetropia eyes were implanted with the other single-piece hydrophilic acrylic IOL (Akreos Adapt, Bausch \&Lomb, AO group).80 eyes implanted with the single-piece hydrophobic acrylic IOL were examined by SSOCT to build the 3-D model of anterior segment.

Methods: 60 eyes were examined by custom-built UL-OCT at 4 hours, 1 day, 7 day, 14 day, 28 day, 3 month, 6 month,12 month after surgery.30 eyes implanted with the single-piece hydrophobic acrylic IOL were recruited for evaluation of the SSOCT reliability.50 eyes were examined by SSOCT at 1 day, 7 day,1 month, 3 months,6 months,12 months after surgery.

Measures: Contact of the anterior and posterior lens capsule with the IOL optic surface was evaluated. Types of capsular bend were described at the last follow-up. The incidence of posterior capsular opacity (PCO) was evaluated.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-05-11
• Study First Submitted QC: 2012-05-24
• Study First Posted: 2012-05-25
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-07
• Last Update Posted: 2015-01-09
• Primary Completion: 2016-09
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Eyes with an AL of 26.00mm or more were recruited to the high myopia group.
• Eyes with an AL of 22.00 to 25.00 mm were recruited to the emmetropia group.

Exclusion Criteria

• Preoperative exclusion criteria included diabetes, history of ocular surgery or inflammation, pupils could not be dilated over 7mm after mydriasis,
• patients who could not be available for follow-up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate Capsular Apposition to Intraocular Lens in high myopia eyes and emmetropia eyes with different types of IOL	4hour, 1day, 7day, 14day, 28day, 3month, 6month, 12month

Trial Locations

Locations (1)

Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China