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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|