Evaluate Capsular Apposition to Intraocular Lens
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
1 other identifier
observational
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 11, 2012
CompletedFirst Posted
Study publicly available on registry
May 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 9, 2015
January 1, 2015
5.4 years
May 11, 2012
January 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
high myopia
high myopia (axial length\>26mm)
emmetropia
emmetropia (22\<axial length\<25mm) as control group.
Eligibility Criteria
This prospective study consisted consecutive patients with high axial myopia (myopia group) and age-matched patients with normal axial length (control group). All eyes underwent uncomplicated phacoemulsification with a single-piece IOL (AcrySof, Alcon) implantation for cataract treatment.
You may qualify if:
- 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.
You may not qualify if:
- patients who could not be available for follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wenzhou Medical University
Wenzhou, Zhejiang, 325027, China
Related Publications (1)
Tao A, Lu P, Li J, Shao Y, Wang J, Shen M, Zhao Y, Lu F. High resolution OCT quantitative analysis of the space between the IOL and the posterior capsule during the early cataract postoperative period. Invest Ophthalmol Vis Sci. 2013 Oct 25;54(10):6991-7. doi: 10.1167/iovs.13-12849.
PMID: 24065808DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
yune zhao, MS
Wenzhou Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor of ophthalmology, Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
May 11, 2012
First Posted
May 25, 2012
Study Start
April 1, 2011
Primary Completion
September 1, 2016
Study Completion
December 1, 2016
Last Updated
January 9, 2015
Record last verified: 2015-01