Back to resultsThe Effect of Cataract Extraction on the Contractility of Ciliary Muscle
Primary Purpose
Presbyopia, Cataract
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
UBM with pilocarpine in presbyopia
Sponsored by
About this trial
This is an interventional basic science trial for Presbyopia focused on measuring presbyopia
Eligibility Criteria
Inclusion Criteria:
- Age : same or more than 55 years
- Patients with senile cataract who are going to get cataract surgery
Exclusion Criteria:
- Age : less than 55 years
- Previous ocular disease other than cataract.
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
ultrasound biomicrocopic examinations and pilocarpine instillation
Outcomes
Primary Outcome Measures
ultrasound biomicroscopic findings (ciliary body axial length)
Secondary Outcome Measures
Full Information
NCT ID
NCT00624039
First Posted
February 18, 2008
Last Updated
February 18, 2008
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00624039
Brief Title
The Effect of Cataract Extraction on the Contractility of Ciliary Muscle
Official Title
The Effect of Cataract Extraction on the Contractility of Ciliary Muscle
Study Type
Interventional
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Unknown status
Study Start Date
May 2006 (undefined)
Primary Completion Date
March 2008 (Anticipated)
Study Completion Date
March 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the changes in the pilocarpine-induced ciliary body movement before and after cataract extraction in order to determine the effect of lens sclerosis on the ciliary muscle contractility.
Detailed Description
The functional changes in the ciliary body in presbyopia are not only important in a study of the mechanism for presbyopia but are also a key to various procedures or devices used to restore accommodation. Therefore, it is becoming increasingly important to quantify the in vivo accommodative changes in the aging ciliary muscle with and without a lens. We are going to evaluate the changes in the pilocarpine-induced contractility of the ciliary muscle in eyes with presbyopia before and after cataract extraction using ultrasound biomicroscopy (UBM).UBM will be performed with and without instilling 2 % pilocarpine, as well as before and 2 months after cataract extraction. Images of the ciliary body will be compared visually using Adobe Photoshop 7.0.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia, Cataract
Keywords
presbyopia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
ultrasound biomicrocopic examinations and pilocarpine instillation
Intervention Type
Other
Intervention Name(s)
UBM with pilocarpine in presbyopia
Other Intervention Name(s)
UBM with pilocarpine
Intervention Description
ultrasound biomicroscopic examination in both eyes 30 minutes after one drop of 2% pilocarpine hydrochloride (Ocucarpine®, Samil Pharm., Seoul, Korea) instillation before and two months after cataract surgery
Primary Outcome Measure Information:
Title
ultrasound biomicroscopic findings (ciliary body axial length)
Time Frame
2 months before and after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age : same or more than 55 years
Patients with senile cataract who are going to get cataract surgery
Exclusion Criteria:
Age : less than 55 years
Previous ocular disease other than cataract.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changwon Kee, M.D.
Organizational Affiliation
Department of Ophthalmology, Samsung Medical Center, Ilwon-dong, Kangnam-gu, Seoul, 135-710, Republic of Korea. E-mail: ckee@skku.edu
Official's Role
Study Director
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
12486512
Citation
Stachs O, Martin H, Kirchhoff A, Stave J, Terwee T, Guthoff R. Monitoring accommodative ciliary muscle function using three-dimensional ultrasound. Graefes Arch Clin Exp Ophthalmol. 2002 Nov;240(11):906-12. doi: 10.1007/s00417-002-0551-2. Epub 2002 Oct 9.
Results Reference
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The Effect of Cataract Extraction on the Contractility of Ciliary Muscle
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