Intraocular PressureNCT02539758
The Effect of Ocular Massage on the Management of Elevated Intraocular Pressure After Acute Angle Closure
A study testing ocular massage, LenstarLS900 and Goldmann tonometer in people with Intraocular Pressure, run by Lv Yingjuan at 1 site in China.
Trial summary
Lowering intraocular pressure remains the mainstay of therapy in the management of glaucoma. The effect of ocular massage on intraocular pressure in patients with acute primary angle closure was the important thing.This was a prospective study, in which 20 eyes from 20 patients had acute angle closure. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- ocular massage, LenstarLS900 and Goldmann tonometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Sep 2014
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All of them had documented evidence of acute angle closure.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300384
About this study
Lowering intraocular pressure remains the mainstay of therapy in the management of glaucoma. The effect of ocular massage on intraocular pressure in patients with acute primary angle closure was the important thing.This was a prospective study, in which 20 eyes from 20 patients had acute angle closure. When they went to the hospital, ocular massage was performed without any medication. Intraocular pressure was detected by Goldmann tonometer, and Lenstar LS900 optical biometry observed changes of anterior chamber depth before and after ocular massage. Anterior chamber depth, anterior chamber angle and ciliary body were observed by Ultrasound biomicroscopy after massage, and anterior chamber angle was also checked by gonioscope after massage.
Read the detailed description
Background: Primary angle closure glaucoma is still the most common type in Asia. Lowering intraocular pressure remains the mainstay of therapy in the management of glaucoma, since it has been shown to be effective in reducing optic nerve damage and loss of vision. The objective of this study was to evaluate to assess the effect of ocular massage on intraocular pressure in patients with acute primary angle closure.
Methods : This was a prospective study, in which 20 eyes from 20 patients had acute angle closure. When they went to the hospital, ocular massage was performed without any medication. Intraocular pressure was detected by Goldmann tonometer, and Lenstar LS900 optical biometry (Lenstar LS900) observed changes of anterior chamber depth before and after ocular massage. Anterior chamber depth, anterior chamber angle and ciliary body were observed by Ultrasound biomicroscopy (after massage, and anterior chamber angle was also checked by gonioscope after massage.
- Conditions
- Intraocular Pressure
- Being tested
- ocular massage, LenstarLS900, Goldmann tonometer
- Keywords
- acute angle closure, ocular massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ocular massageOther
ocular massage could be applied over the globe over the closed eyelids with moderate massage strength for 15 minutes. The compression of the globe was given with finger, and press for 2 seconds, then by a 2 seconds release, with a frequency of 15 presses/minute.
LenstarLS900Device
observed changes of anterior chamber depth before and after ocular massage by LenstarLS900
Goldmann tonometerDevice
observed changes of intraocular pressure before and after ocular massage by Goldmann tonometer
| Study group | Role | What they receive |
|---|---|---|
| ocular massage | Experimental | over the closed eyelids with moderate massage strength for 15 minutes. The compression of the globe was given with finger, and press for 2 seconds, then by a 2 seconds release, with a frequency of 15 presses/minute.We observed changes of anterior chamber depth before and after ocular massage by LenstarLS900,and changes of intraocular pressure before and after ocular massage by Goldmann tonometer Receives: Other: ocular massage; Device: LenstarLS900; Device: Goldmann tonometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
observed changes of anterior chamber depth before and after ocular massage
Measured: before ocular massage and 15 minutes after massage
Secondary outcomes (1)
observed changes of intraocular pressure before and after ocular massage
Measured: before ocular massage and 15 minutes after massage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lv Yingjuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lv Yingjuan, Tianjin Medical University Eye Hospital
- Investigators
- yingjuan Lv, Principal investigator, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539758
- Sponsor's protocol ID
- tjykdxykyy2
- Status last verified
- Aug 2015
- First submitted
- 8 Aug 2015
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ocular Massage on the Management of Elevated Intraocular Pressure After Acute Angle Closure
- ClinicalTrials.gov ID
- NCT02539758
- Acronym / sponsor ID
- tjykdxykyy2
- Conditions
- Intraocular Pressure
- Keywords
- acute angle closure, ocular massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lv YingjuanUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Sep 2015 (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.
Lowering intraocular pressure remains the mainstay of therapy in the management of glaucoma. The effect of ocular massage on intraocular pressure in patients with acute primary angle closure was the important thing.This was a prospective study, in which 20 eyes from 20 patients had acute angle closure. When they went to the hospital, ocular massage was performed without any medication. Intraocular pressure was detected by Goldmann tonometer, and Lenstar LS900 optical biometry observed changes of anterior chamber depth before and after ocular massage. Anterior chamber depth, anterior chamber angle and ciliary body were observed by Ultrasound biomicroscopy after massage, and anterior chamber angle was also checked by gonioscope after massage.
Detailed description
Background: Primary angle closure glaucoma is still the most common type in Asia. Lowering intraocular pressure remains the mainstay of therapy in the management of glaucoma, since it has been shown to be effective in reducing optic nerve damage and loss of vision. The objective of this study was to evaluate to assess the effect of ocular massage on intraocular pressure in patients with acute primary angle closure.
Methods : This was a prospective study, in which 20 eyes from 20 patients had acute angle closure. When they went to the hospital, ocular massage was performed without any medication. Intraocular pressure was detected by Goldmann tonometer, and Lenstar LS900 optical biometry (Lenstar LS900) observed changes of anterior chamber depth before and after ocular massage. Anterior chamber depth, anterior chamber angle and ciliary body were observed by Ultrasound biomicroscopy (after massage, and anterior chamber angle was also checked by gonioscope after massage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ocular massage | Experimental | Other: ocular massage, Device: LenstarLS900, Device: Goldmann tonometerover the closed eyelids with moderate massage strength for 15 minutes. The compression of the globe was given with finger, and press for 2 seconds, then by a 2 seconds release, with a frequency of 15 presses/minute.We observed changes of anterior chamber depth before and after ocular massage by LenstarLS900,and changes of intraocular pressure before and after ocular massage by Goldmann tonometer |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All of them had documented evidence of acute angle closure.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| ocular massageocular massage could be applied over the globe over the closed eyelids with moderate massage strength for 15 minutes. The compression of the globe was given with finger, and press for 2 seconds, then by a 2 seconds release, with a frequency of 15 presses/minute. | Other | ocular massage |
| LenstarLS900observed changes of anterior chamber depth before and after ocular massage by LenstarLS900 | Device | ocular massage |
| Goldmann tonometerobserved changes of intraocular pressure before and after ocular massage by Goldmann tonometer | Device | ocular massage |
Primary outcome
observed changes of anterior chamber depth before and after ocular massage
Time frame: before ocular massage and 15 minutes after massage
1 secondary outcome
observed changes of intraocular pressure before and after ocular massage
Time frame: before ocular massage and 15 minutes after massage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
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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.
yingjuan Lv principal investigator
Tianjin Medical University Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ocular massage, LenstarLS900 and Goldmann tonometer in people with Intraocular Pressure, run by Lv Yingjuan at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Sep 2015. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
observed changes of anterior chamber depth before and after ocular massage (time frame: before ocular massage and 15 minutes after massage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2015.