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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 Wenzhou Medical University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
yin ying zhao, Wenzhou Medical University Identifier:
First received: May 11, 2012
Last updated: January 7, 2015
Last verified: January 2015
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.

Capsule Opacification
Tissue Adhesions
Aphakia - Lens Capsule Present
Opacification of Intraocular Lens

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Further study details as provided by Wenzhou Medical University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: April 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
high myopia
high myopia (axial length>26mm)
emmetropia (22<axial length<25mm) as control group.

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01605812

Contact: yinying zhao, PhD 86-057788068859

China, Zhejiang
Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325027
Contact: XIXIA DING, PHD    86-057788068859      
Sponsors and Collaborators
Wenzhou Medical University
Study Chair: yune zhao, MS Wenzhou Medical University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: yin ying zhao, doctor of ophthalmology, Principal Investigator, Clinical Professor, Wenzhou Medical University Identifier: NCT01605812     History of Changes
Other Study ID Numbers: WZYXY-ZYY-OCT
Study First Received: May 11, 2012
Last Updated: January 7, 2015

Keywords provided by Wenzhou Medical University:

Additional relevant MeSH terms:
Capsule Opacification
Tissue Adhesions
Lens Diseases
Eye Diseases
Pathologic Processes processed this record on May 24, 2017