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Evaluate Capsular Apposition to Intraocular Lens

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by yin ying zhao, Wenzhou Medical University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01605812
First Posted: May 25, 2012
Last Update Posted: January 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
yin ying zhao, Wenzhou Medical University
May 11, 2012
May 25, 2012
January 9, 2015
April 2011
September 2016   (Final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT01605812 on ClinicalTrials.gov Archive Site
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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
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample
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.
  • Capsule Opacification
  • Tissue Adhesions
  • Aphakia - Lens Capsule Present
  • Opacification of Intraocular Lens
Not Provided
  • high myopia
    high myopia (axial length>26mm)
  • emmetropia
    emmetropia (22<axial length<25mm) as control group.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
150
December 2016
September 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01605812
WZYXY-ZYY-OCT
Yes
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yin ying zhao, Wenzhou Medical University
Wenzhou Medical University
Not Provided
Study Chair: yune zhao, MS Wenzhou Medical University
Wenzhou Medical University
January 2015