CataractPhase 4NCT00386438
Efficacy of Honan Balloon in Intraocular Pressure Reduction Before Phacoemulsification
A Phase 4 study testing Honan balloon application in people with Cataract, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
-Does Honan balloon reduce intraocular pressure preoperatively? Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Honan balloon application
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteThailand
- Study dates
- Dec 2005to Jul 2006
- Phase
- Phase 4
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- cataract patient,who plan to undergo phacoemulsification
- no previous ocular surgery
Who cannot join
- one eye
- high myopia
- Use ASA or anticoagulants
- History of glaucoma or ocular hypertension
- uncooperative patients
Trial locations and contacts
1 site in 1 country.
About this study
-Does Honan balloon reduce intraocular pressure preoperatively?
Read the detailed description
-Does Honan balloon improve surgeon's satisfaction and patients' pain score when compared to no honan group?
- Conditions
- Cataract
- Being tested
- Honan balloon application
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honan balloon applicationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure reduction
Secondary outcomes (1)
pain score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startDec 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Investigators
- Thitima Lunchakonsiripan, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386438
- Sponsor's protocol ID
- 391/47
- Status last verified
- Oct 2006
- First submitted
- 10 Oct 2006
- Last updated
- 11 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Honan Balloon in Intraocular Pressure Reduction Before Phacoemulsification
- ClinicalTrials.gov ID
- NCT00386438
- Acronym / sponsor ID
- 391/47
- Conditions
- Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Dec 2005
- Study completion
- Jul 2006
- First posted
- 11 Oct 2006 (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.
-Does Honan balloon reduce intraocular pressure preoperatively?
Detailed description
-Does Honan balloon improve surgeon's satisfaction and patients' pain score when compared to no honan group?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- cataract patient,who plan to undergo phacoemulsification
- no previous ocular surgery
Key exclusion criteria (5 listed)
- one eye
- high myopia
- Use ASA or anticoagulants
- History of glaucoma or ocular hypertension
- uncooperative patients
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 |
|---|---|---|
| Honan balloon application | Procedure or surgery | – |
Primary outcome
intraocular pressure reduction
1 secondary outcome
pain score
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 11 Oct 2006.
- Faculty of Medicine,Chulalongkorn UniversityLink provided by the sponsor.
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Effects of Oxygen Cage Support During Cataract Surgery
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Age-Related Eye Disease Study (AREDS) Follow-Up
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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.
Thitima Lunchakonsiripan, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Honan balloon application in people with Cataract, run by Chulalongkorn University at 1 site in Thailand.
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 5 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 11 Oct 2006. 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 Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
intraocular pressure reduction. 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 11 Oct 2006.