Intraocular Pressure ChangesNCT01468103
Laser Iridotomy Versus Surgical Iridectomy in Early Angle Closure
A study testing Surgical Iridectomy and Laser Iridotomy in people with Intraocular Pressure Changes and Peripheral Anterior Synechiae Increasing, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a randomized controlled clinical trial to compare laser peripheral iridotomy(LPI) and surgical peripheral iridectomy. Subjects of primary angle closure suspect, primary angle closure will be randomized to undergo LPI or SPI. Subjects are proposed to be followed up for 3 years. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Intraocular Pressure Changes, Peripheral Anterior Synechiae Increasing
- What is being tested?
- Surgical Iridectomy and Laser Iridotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Aug 2009to Aug 2012
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- more than 50 years old
- Diagnosis of either: Primary angle closure suspects, Primary angle closure in need of laser iridotomy or surgical iridectomy
- Able to give Informed concent
Who cannot join
- Ophthalmic diseases other than glaucoma and cataract
- pseudophakic or aphakic patients
- inability to attend regular follow-up assessment or to give informed written consent
- Secondary causes of angle closure e.g. subluxed lens, uveitis, trauma and neovascular glaucoma
- Participating in another study
- monocular patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ZhongShan Ophthalmic Center
Guangzhou, Guangdong, 510060
Gao Xinbo, MD, ice.freeport@163.com
Gao Xinbo, MD
About this study
Official title: Laser Peripheral Iridotomy Versus Surgical Peripheral Iridectomy in Early Angle Closure:a Randomized Clinical Trial
This is a randomized controlled clinical trial to compare laser peripheral iridotomy(LPI) and surgical peripheral iridectomy. Subjects of primary angle closure suspect, primary angle closure will be randomized to undergo LPI or SPI. Subjects are proposed to be followed up for 3 years.
Read the detailed description
The following will be studied:
- To evaluate the safety of these two techniques for the treatment of angle closure.
- To compare the anterior chamber reaction and IOP changes post surgery.
- TO establish the UBM/ASOCT chamber angle parameters changes pre and post surgery.
- To assess the development of PAS.
- Being tested
- Surgical Iridectomy, Laser Iridotomy
- Keywords
- intraocular pressure, Peripheral anterior synechiae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical IridectomyProcedure or surgery
Also called Peripheral Surgical Iridectomy
Surgical Iridectomy is now widely used in our clinical.
Laser IridotomyProcedure or surgery
Also called Peripheral Laser Iridotomy
alternative choice to surgical iridectomy
| Study group | Role | What they receive |
|---|---|---|
| PACS | Experimental | primary angle closure suspects Receives: Procedure: Surgical Iridectomy; Procedure: Laser Iridotomy |
| PAC | Experimental | primary angle closure Receives: Procedure: Surgical Iridectomy; Procedure: Laser Iridotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure
Measured: 3 years
Secondary outcomes (1)
Angle assessment parameters
Angle assessment parameters,such as anterior chamber openning distance,are acquired by anterior segment optical coherence tomography.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startAug 2009
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular Pressure ChangesStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Xinbo, Sun Yat-sen University
- Investigators
- Zhang X Lan, MD, Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468103
- Sponsor's protocol ID
- 19831105gaoxinbo
- Status last verified
- Nov 2011
- First submitted
- 6 Nov 2011
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Peripheral Iridotomy Versus Surgical Peripheral Iridectomy in Early Angle Closure:a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01468103
- Acronym / sponsor ID
- 19831105gaoxinbo
- Keywords
- intraocular pressure, Peripheral anterior synechiae
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 9 Nov 2011 (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.
This is a randomized controlled clinical trial to compare laser peripheral iridotomy(LPI) and surgical peripheral iridectomy. Subjects of primary angle closure suspect, primary angle closure will be randomized to undergo LPI or SPI. Subjects are proposed to be followed up for 3 years.
Detailed description
The following will be studied:
- To evaluate the safety of these two techniques for the treatment of angle closure.
- To compare the anterior chamber reaction and IOP changes post surgery.
- TO establish the UBM/ASOCT chamber angle parameters changes pre and post surgery.
- To assess the development of PAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PACS | Experimental | Procedure: Surgical Iridectomy, Procedure: Laser Iridotomyprimary angle closure suspects |
| PAC | Experimental | Procedure: Surgical Iridectomy, Procedure: Laser Iridotomyprimary angle closure |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- more than 50 years old
- Diagnosis of either: Primary angle closure suspects, Primary angle closure in need of laser iridotomy or surgical iridectomy
- Able to give Informed concent
Key exclusion criteria (6 listed)
- Ophthalmic diseases other than glaucoma and cataract
- pseudophakic or aphakic patients
- inability to attend regular follow-up assessment or to give informed written consent
- Secondary causes of angle closure e.g. subluxed lens, uveitis, trauma and neovascular glaucoma
- Participating in another study
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 |
|---|---|---|
| Surgical IridectomyAlso: Peripheral Surgical IridectomySurgical Iridectomy is now widely used in our clinical. | Procedure or surgery | PAC, PACS |
| Laser IridotomyAlso: Peripheral Laser Iridotomyalternative choice to surgical iridectomy | Procedure or surgery | PAC, PACS |
Primary outcome
intraocular pressure
Time frame: 3 years
1 secondary outcome
Angle assessment parameters
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2011.
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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.
Zhang X Lan, MD study director
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Iridectomy and Laser Iridotomy in people with Intraocular Pressure Changes and Peripheral Anterior Synechiae Increasing, run by Sun Yat-sen University 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 3 inclusion and 6 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 9 Nov 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraocular pressure (time frame: 3 years). 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 9 Nov 2011.