Evaluate Capsular Apposition to Intraocular Lens
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|ClinicalTrials.gov Identifier: NCT01605812|
Recruitment Status : Unknown
Verified January 2015 by yin ying zhao, Wenzhou Medical University.
Recruitment status was: Recruiting
First Posted : May 25, 2012
Last Update Posted : January 9, 2015
|Condition or disease|
|Capsule Opacification Tissue Adhesions Aphakia - Lens Capsule Present Opacification of Intraocular Lens|
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 Type :||Observational|
|Estimated Enrollment :||150 participants|
|Observational Model:||Case Control|
|Official Title:||Phase 1 Evaluate Capsular Apposition to Intraocular Lens in Subjects With High Myopia by Ultra-long Scan Depth Optical Coherence Tomography; Phase 2 Evaluate Capsular Apposition to Different Types of Intraocular Lens in Subjects|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||December 2016|
high myopia (axial length>26mm)
emmetropia (22<axial length<25mm) as control group.
- Evaluate Capsular Apposition to Intraocular Lens in high myopia eyes and emmetropia eyes with different types of IOL [ Time Frame: 4hour, 1day, 7day, 14day, 28day, 3month, 6month, 12month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605812
|Contact: yinying zhao, PhDemail@example.com|
|Wenzhou Medical University||Recruiting|
|Wenzhou, Zhejiang, China, 325027|
|Contact: XIXIA DING, PHD 86-057788068859|
|Study Chair:||yune zhao, MS||Wenzhou Medical University|