NCT00624039

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

February 26, 2008

Status Verified

May 1, 2006

Enrollment Period

1.8 years

First QC Date

February 18, 2008

Last Update Submit

February 18, 2008

Conditions

PresbyopiaCataract

Keywords

presbyopia

Outcome Measures

Primary Outcomes (1)

  • ultrasound biomicroscopic findings (ciliary body axial length)

    2 months before and after surgery

Study Arms (1)

1

OTHER

ultrasound biomicrocopic examinations and pilocarpine instillation

Other: UBM with pilocarpine in presbyopia

Interventions

UBM with pilocarpine in presbyopiaOTHER

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

Also known as: UBM with pilocarpine
1

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age : same or more than 55 years
  • Patients with senile cataract who are going to get cataract surgery

You may not qualify if:

  • Age : less than 55 years
  • Previous ocular disease other than cataract.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 12486512BACKGROUND

MeSH Terms

Conditions

PresbyopiaCataract

Interventions

Pilocarpine

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Changwon Kee, M.D.

    Department of Ophthalmology, Samsung Medical Center, Ilwon-dong, Kangnam-gu, Seoul, 135-710, Republic of Korea. E-mail: ckee@skku.edu

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 18, 2008

First Posted

February 26, 2008

Study Start

May 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

February 26, 2008

Record last verified: 2006-05

Locations

KR(1)