Acute Angle-Closure GlaucomaNCT04912310
Efficacy Evaluation and Influencing Factors of Argon Laser Peripheral Iridoplasty in Acute Angle Closure Glaucoma
A study testing Argon laser peripheral iridoplasty in people with Acute Angle-Closure Glaucoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To investigate the changes of angle structure and intraocular pressure after argon laser peripheral iridoplasty in patients with acute angle closure glaucoma patients whose intraocular pressure could not be controlled by drug therapy during the major attack period. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Angle-Closure Glaucoma
- What is being tested?
- Argon laser peripheral iridoplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2020to Jul 2021
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- One eye had an acute attack, which could not be relieved by medication, and the intraocular pressure was more than 21mmhg;
- The patients were 40 to 80 years old, regardless of gender;
- Patients are able and willing to comply with the research guidance and may complete all visits required by the research;
- Informed consent has been signed.
Who cannot join
- History of ocular trauma;
- Any previous intraocular surgery;
- Secondary glaucoma was diagnosed, including uveitis, neovascular glaucoma, glaucoma with elevated superior scleral venous pressure, lens dissolution glaucoma, glaucoma caused by lens dislocation, lens cortical glaucoma, pigmented glaucoma, etc;
- The patient's history indicated that he had severe dysfunction of heart, lung, liver and kidney;
- Women in pregnancy, lactation or planned pregnancy;
- The researchers believe that the patient's condition may put the patient at a significant risk, may confuse the results of the study, or may significantly interfere with the patient's participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye center, 2nd Affiliated Hospital, School of Medicine, Zhejiang University,
Hangzhou, Zhejiang
Kaijun Wang, MD, +86 0571 87783759, wkj992@126.com
Kaijun Wang, MD
About this study
To investigate the changes of angle structure and intraocular pressure after argon laser peripheral iridoplasty in patients with acute angle closure glaucoma patients whose intraocular pressure could not be controlled by drug therapy during the major attack period.
Read the detailed description
To evaluate intraocular pressure and anterior segment optical coherence tomography measurement parameters at baseline and each follow-up. Each patient was followed up for 6 weeks for 9 times. Visit 1st was baseline examination, visit 2nd was 1 hour after argon laser peripheral iridoplasty treatment, visit 3rd was 2 hours after argon laser peripheral iridoplasty treatment, visit 4th was 1 week after argon laser peripheral iridoplasty treatment, visit 5th was 2 week after argon laser peripheral iridoplasty treatment, and visit 6th was 1 month after argon laser peripheral iridoplasty treatment, visit 7th was 6 week after argon laser peripheral iridoplasty treatment.
- Conditions
- Acute Angle-Closure Glaucoma
- Being tested
- Argon laser peripheral iridoplasty
- Keywords
- Acute angle-closure glaucoma, Argon laser peripheral iridoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argon laser peripheral iridoplastyDevice
Argon laser peripheral iridoplasty was performed in patients with severe acute angle closure glaucoma whose intraocular pressure could not be controlled by medication
| Study group | Role | What they receive |
|---|---|---|
| Acute angle closure glaucoma | Experimental | Argon laser peripheral iridoplasty Receives: Device: Argon laser peripheral iridoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Intraocular pressure
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start13 Jul 2020
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Angle-Closure GlaucomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- kaijun wang, MD, Study director, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912310
- Sponsor's protocol ID
- 2020-480
- Status last verified
- Jul 2020
- First submitted
- 31 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation and Influencing Factors of Argon Laser Peripheral Iridoplasty in Acute Angle Closure Glaucoma
- ClinicalTrials.gov ID
- NCT04912310
- Acronym / sponsor ID
- 2020-480
- Conditions
- Acute Angle-Closure Glaucoma
- Keywords
- Acute angle-closure glaucoma, Argon laser peripheral iridoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 3 Jun 2021 (actual)
- 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.
To investigate the changes of angle structure and intraocular pressure after argon laser peripheral iridoplasty in patients with acute angle closure glaucoma patients whose intraocular pressure could not be controlled by drug therapy during the major attack period.
Detailed description
To evaluate intraocular pressure and anterior segment optical coherence tomography measurement parameters at baseline and each follow-up. Each patient was followed up for 6 weeks for 9 times. Visit 1st was baseline examination, visit 2nd was 1 hour after argon laser peripheral iridoplasty treatment, visit 3rd was 2 hours after argon laser peripheral iridoplasty treatment, visit 4th was 1 week after argon laser peripheral iridoplasty treatment, visit 5th was 2 week after argon laser peripheral iridoplasty treatment, and visit 6th was 1 month after argon laser peripheral iridoplasty treatment, visit 7th was 6 week after argon laser peripheral iridoplasty treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute angle closure glaucoma | Experimental | Device: Argon laser peripheral iridoplastyArgon laser peripheral iridoplasty |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- One eye had an acute attack, which could not be relieved by medication, and the intraocular pressure was more than 21mmhg;
- The patients were 40 to 80 years old, regardless of gender;
- Patients are able and willing to comply with the research guidance and may complete all visits required by the research;
- Informed consent has been signed.
Key exclusion criteria (6 listed)
- History of ocular trauma;
- Any previous intraocular surgery;
- Secondary glaucoma was diagnosed, including uveitis, neovascular glaucoma, glaucoma with elevated superior scleral venous pressure, lens dissolution glaucoma, glaucoma caused by lens dislocation, lens cortical glaucoma, pigmented glaucoma, etc;
- The patient's history indicated that he had severe dysfunction of heart, lung, liver and kidney;
- Women in pregnancy, lactation or planned pregnancy;
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 |
|---|---|---|
| Argon laser peripheral iridoplastyArgon laser peripheral iridoplasty was performed in patients with severe acute angle closure glaucoma whose intraocular pressure could not be controlled by medication | Device | Acute angle closure glaucoma |
Primary outcome
Intraocular pressure
Time frame: 6 weeks
Intraocular pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
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.
kaijun wang, MD study director
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Argon laser peripheral iridoplasty in people with Acute Angle-Closure Glaucoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 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 3 Jun 2021. 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?
Contact kaijun wang, MD (+86 0571 87783759, wkj992@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (time frame: 6 weeks). 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 Jun 2021.