Evaluate Capsular Apposition to Intraocular Lens

NCT ID: NCT01605812

Last Updated: 2015-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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high myopia

high myopia (axial length\>26mm)

No interventions assigned to this group

emmetropia

emmetropia (22\<axial length\<25mm) as control group.

No interventions assigned to this group

Eligibility Criteria

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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

* patients who could not be available for follow-up.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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yin ying zhao

doctor of ophthalmology, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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yune zhao, MS

Role: STUDY_CHAIR

Wenzhou Medical University

Locations

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Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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yinying zhao, PhD

Role: CONTACT

86-057788068859

Facility Contacts

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XIXIA DING, PHD

Role: primary

86-057788068859

References

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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.

Reference Type DERIVED
PMID: 24065808 (View on PubMed)

Other Identifiers

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WZYXY-ZYY-OCT

Identifier Type: -

Identifier Source: org_study_id

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