PresbyopiaNCT00624039
The Effect of Cataract Extraction on the Contractility of Ciliary Muscle
A study testing UBM with pilocarpine in presbyopia in people with Presbyopia and Cataract, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Presbyopia, Cataract
- What is being tested?
- UBM with pilocarpine in presbyopia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2006to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age : same or more than 55 years
- Patients with senile cataract who are going to get cataract surgery
Who cannot join
- Age : less than 55 years
- Previous ocular disease other than cataract.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Presbyopia, Cataract
- Being tested
- UBM with pilocarpine in presbyopia
- Keywords
- presbyopia
- Medical subject headings
- Presbyopia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UBM with pilocarpine in presbyopiaOther
Also called UBM with pilocarpine
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | ultrasound biomicrocopic examinations and pilocarpine instillation Receives: Other: UBM with pilocarpine in presbyopia |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound biomicroscopic findings (ciliary body axial length)
Measured: 2 months before and after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startMay 2006
- Primary completionMar 2008 (estimated)
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Changwon Kee, M.D., Study director, Department of Ophthalmology, Samsung Medical Center, Ilwon-dong, Kangnam-gu, Seoul, 135-710, Republic of Korea. E-mail: ckee@skku.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624039
- Sponsor's protocol ID
- CB2006
- Status last verified
- May 2006
- First submitted
- 18 Feb 2008
- Last updated
- 26 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12486512
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cataract Extraction on the Contractility of Ciliary Muscle
- ClinicalTrials.gov ID
- NCT00624039
- Acronym / sponsor ID
- CB2006
- Conditions
- Presbyopia, Cataract
- Keywords
- presbyopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Mar 2008 (estimated)
- Study completion
- Mar 2008 (estimated)
- First posted
- 26 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: UBM with pilocarpine in presbyopiaultrasound biomicrocopic examinations and pilocarpine instillation |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age : same or more than 55 years
- Patients with senile cataract who are going to get cataract surgery
Key exclusion criteria (2 listed)
- Age : less than 55 years
- Previous ocular disease other than cataract.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UBM with pilocarpine in presbyopiaAlso: UBM with pilocarpineultrasound 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 | Other | 1 |
Primary outcome
ultrasound biomicroscopic findings (ciliary body axial length)
Time frame: 2 months before and after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2008.
- Background: PubMed 12486512Stachs 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changwon Kee, M.D. study director
Department of Ophthalmology, Samsung Medical Center, Ilwon-dong, Kangnam-gu, Seoul, 135-710, Republic of Korea. E-mail: ckee@skku.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UBM with pilocarpine in presbyopia in people with Presbyopia and Cataract, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasound biomicroscopic findings (ciliary body axial length) (time frame: 2 months before and after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00624039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2008.