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Status unknownNCT01605812Updated Jan 9, 2015

Evaluate Capsular Apposition to Intraocular Lens

An observational study in Capsule Opacification, Tissue Adhesions and Aphakia - Lens Capsule Present, sponsored by Wenzhou Medical University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2015-01-09.

Sponsored by Wenzhou Medical University · Observational

The sponsor has not verified this record recently (last verified Jan 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • IOL;
  • capsule;
  • PCO;
  • OCT
03

In context

Aphakia

70 studies on the registry are indexed under Aphakia; 7 are open to participants now.

This study's planned enrollment of 150 is above the median of 95 across 13 observational studies indexed under Aphakia.

Browse Aphakia studies →

Lead sponsor

Wenzhou Medical University is the lead sponsor of 93 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • high myopia

    high myopia (axial length\>26mm)

  • emmetropia

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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Wenzhou Medical University
    Wenzhou, Zhejiang 325027, China
    • XIXIA DING, PHD · Contact · 86-057788068859
    Recruiting
08

References and documents

Publications

  • 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. PubMed 24065808 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01605812
Lead sponsor
Wenzhou Medical University
Responsible party
yin ying zhao (doctor of ophthalmology, Principal Investigator, Clinical Professor, Wenzhou Medical University) — Principal investigator
First posted
May 25, 2012
Start date
Apr 2011
Primary completion
Sep 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Jan 9, 2015

Study contacts

yinying zhao, PhD
Contact
ginger146@126.com
86-057788068859
yune zhao, MS
study chair · Wenzhou Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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