Text Size

Evaluate Capsular Apposition to Intraocular Lens

This study is currently recruiting participants.
Verified June 2013 by Wenzhou Medical University
Sponsor:
Information provided by (Responsible Party):
yin ying zhao, Wenzhou Medical College
ClinicalTrials.gov Identifier:
NCT01605812
First received: May 11, 2012
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition
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

Resource links provided by NLM:

MedlinePlus related topics: Adhesions
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
high myopia
high myopia (axial length>26mm)
emmetropia
emmetropia (22<axial length<25mm) as control group.

Detailed Description:

Forty eyes of 60 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).

Methods: All 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.

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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605812

Contacts
Contact: yinying zhao, PhD 86-057788068859 ginger146@126.com

Locations
China, Zhejiang
Wenzhou Medical College Recruiting
Wenzhou, Zhejiang, China, 325027
Contact: weilin lu, MD     86-057788068859        
Sponsors and Collaborators
Wenzhou Medical University
Investigators
Study Chair: fan lu, MS Wenzhou Medical University
  More Information

No publications provided

Responsible Party: yin ying zhao, doctor of ophthalmology, Principal Investigator, Clinical Professor, Wenzhou Medical College
ClinicalTrials.gov Identifier: NCT01605812     History of Changes
Other Study ID Numbers: WZYXY-ZYY-OCT
Study First Received: May 11, 2012
Last Updated: June 3, 2013
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Keywords provided by Wenzhou Medical University:
IOL;
capsule；
PCO;
OCT

Additional relevant MeSH terms:
Tissue Adhesions
Aphakia
Capsule Opacification
Cicatrix
Fibrosis
 Pathologic Processes
Lens Diseases
Eye Diseases
Cataract

ClinicalTrials.gov processed this record on June 18, 2013