Evaluate Capsular Apposition to Intraocular Lens
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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: Cohort 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 |
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 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 40 cataract patients scheduled for phacoemulsification surgery were recruited, of which 20 eyes were high myopia (AL > 26mm) and 20 eyes were emmetropia (22 < AL < 25mm) as control group.
Methods: All eyes were examined by custom-built UL-OCT at 4 hours, 1 day, 7 days, 14 days, and 28 days after surgery.
Main Outcome 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 |
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| Contact: yin ying zhao, PhD | 86-057788068859 | ginger146@126.com |
| China, Zhejiang | |
| Wenzhou Medical College | Recruiting |
| Wenzhou, Zhejiang, China, 325027 | |
| Contact: weilin lu, MD 86-057788068859 | |
| Study Chair: | yune zhao, MD | Wenzhou Medical College |
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: | December 18, 2012 |
| Health Authority: | China: State Administration of Traditional Chinese Medicine of the People's Republic of China |
Keywords provided by Wenzhou Medical College:
|
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 May 21, 2013