Primary Angle Closure GlaucomaNCT02279472
Optical Coherence Tomography Quantitative Analysis of Changes in Anterior Chamber After Laser Peripheral Lridotomy
A study testing Laserex Tango Nd:YAG, Ellex-SuperQ Medical, Australia in people with Primary Angle Closure Glaucoma, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The purpose of this study is to analysis changes in anterior segment morphology after laser peripheral lrldotomy measured by optical coherence tomography, and to evaluate treatment effectiveness Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Primary Angle Closure Glaucoma
- What is being tested?
- Laserex Tango Nd:YAG, Ellex-SuperQ Medical, Australia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Jan 2015
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 .The gonioscopy or UBM examination has confirmed the diagnosis of PACS or PAC 2. Intraocular pressure within 10 to 21 mmHg ，C/D≤0.6 3. Visual field is normal or only show paracentral scotoma 4. Vision or corrected visual acuity ≥0.8 5. Refractive degree no more than 200D 6. Exclude other ocular and systemic diseases
- -
Who cannot join
- Corneal macula and other corneal diseases, ocular surface disease or corneal edema
- Iridocyclitis
- Ocular trauma and intraocular operation history
- No fixationFundus lesions such as diabetic retinopathy or retinal detachment
- No fixation
- Ocular or systemic application of cortical steroids -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Xiangya Hospital of Central South University,
Changsha, Hunan, 410000
Haomin Luo, Ph.D student, +86 13875830738, lhmqqpp@163.com
About this study
The purpose of this study is to analysis changes in anterior segment morphology after laser peripheral lrldotomy measured by optical coherence tomography, and to evaluate treatment effectiveness
Read the detailed description
In the study ,primary angle closure(PAC) and primary angle closure glaucoma (PACG) will be recruited. Anterior segment optical coherence tomography images captured before and after laser peripheral iridotomy will be analysed to provide objective and reproducible quantification of anterior segment biometric parameters.The outcomes can provide useful information for clinical strategies in the treatment and management of pathology related to angle closure.
- Conditions
- Primary Angle Closure Glaucoma
- Being tested
- Laserex Tango Nd:YAG, Ellex-SuperQ Medical, Australia
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laserex Tango Nd:YAG, Ellex-SuperQ Medical, AustraliaProcedure or surgery
All the patients will be achieved with pilocarpine 1% for pupil constriction, laser peripheral iridotomy(LPI) is performed using the ophthalmic neodymium: yttrium aluminium garnet laser (Laserex Tango Nd:YAG, Ellex-SuperQ Medical, Australia) and an VOLK iridotomy contact lens. After LPI, patients will be given topical prednisolone acetate 0.1% for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| laser peripheral iridotomy | Other | Laser peripheral iridotomy (LPI) is widely regarded as the first-line intervention for either acute or chronic types of angle-closure glaucoma in early stage ,which relieves pupil block and thus flattening the iris contour and widening the drainage angle,performd by Nd.YAG LASER Receives: Procedure: Laserex Tango Nd:YAG, Ellex-SuperQ Medical, Australia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in anterior chamber after LPI at 1 month
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Angle Closure GlaucomaStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haomin Luo, Second Xiangya Hospital of Central South University
- Investigators
- Xuanchu Duan, Ph.D, Study director, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279472
- Sponsor's protocol ID
- SecondXHCSU
- Status last verified
- Oct 2014
- First submitted
- 30 Sep 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Memarzadeh F, Li Y, Chopra V, Varma R, Francis BA, Huang D. Anterior segment optical coherence tomography for imaging the anterior chamber after laser peripheral iridotomy. Am J Ophthalmol. 2007 May;143(5):877-9. doi: 10.1016/j.ajo.2006.11.055. Epub 2006 Dec 29.
PubMed 17452177Lee KS, Sung KR, Shon K, Sun JH, Lee JR. Longitudinal changes in anterior segment parameters after laser peripheral iridotomy assessed by anterior segment optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 May 3;54(5):3166-70. doi: 10.1167/iovs.13-11630.
PubMed 23599331
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Quantitative Analysis of Changes in Anterior Chamber After Laser Peripheral Lridotomy
- ClinicalTrials.gov ID
- NCT02279472
- Acronym / sponsor ID
- SecondXHCSU
- Conditions
- Primary Angle Closure Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 31 Oct 2014 (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 analysis changes in anterior segment morphology after laser peripheral lrldotomy measured by optical coherence tomography, and to evaluate treatment effectiveness
Detailed description
In the study ,primary angle closure(PAC) and primary angle closure glaucoma (PACG) will be recruited. Anterior segment optical coherence tomography images captured before and after laser peripheral iridotomy will be analysed to provide objective and reproducible quantification of anterior segment biometric parameters.The outcomes can provide useful information for clinical strategies in the treatment and management of pathology related to angle closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laser peripheral iridotomy | Other | Procedure: Laserex Tango Nd:YAG, Ellex-SuperQ Medical, AustraliaLaser peripheral iridotomy (LPI) is widely regarded as the first-line intervention for either acute or chronic types of angle-closure glaucoma in early stage ,which relieves pupil block and thus flattening the iris contour and widening the drainage angle,performd by Nd.YAG LASER |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1 .The gonioscopy or UBM examination has confirmed the diagnosis of PACS or PAC 2. Intraocular pressure within 10 to 21 mmHg ，C/D≤0.6 3. Visual field is normal or only show paracentral scotoma 4. Vision or corrected visual acuity ≥0.8 5. Refractive degree no more than 200D 6. Exclude other ocular and systemic diseases
- -
Key exclusion criteria (6 listed)
- Corneal macula and other corneal diseases, ocular surface disease or corneal edema
- Iridocyclitis
- Ocular trauma and intraocular operation history
- No fixationFundus lesions such as diabetic retinopathy or retinal detachment
- No fixation
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 |
|---|---|---|
| Laserex Tango Nd:YAG, Ellex-SuperQ Medical, AustraliaAll the patients will be achieved with pilocarpine 1% for pupil constriction, laser peripheral iridotomy(LPI) is performed using the ophthalmic neodymium: yttrium aluminium garnet laser (Laserex Tango Nd:YAG, Ellex-SuperQ Medical, Australia) and an VOLK iridotomy contact lens. After LPI, patients will be given topical prednisolone acetate 0.1% for 7 days. | Procedure or surgery | laser peripheral iridotomy |
Primary outcome
Changes in anterior chamber after LPI at 1 month
Time frame: 1month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
- Background: PubMed 17452177Memarzadeh F, Li Y, Chopra V, Varma R, Francis BA, Huang D. Anterior segment optical coherence tomography for imaging the anterior chamber after laser peripheral iridotomy. Am J Ophthalmol. 2007 May;143(5):877-9. doi: 10.1016/j.ajo.2006.11.055. Epub 2006 Dec 29.
- Background: PubMed 23599331Lee KS, Sung KR, Shon K, Sun JH, Lee JR. Longitudinal changes in anterior segment parameters after laser peripheral iridotomy assessed by anterior segment optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 May 3;54(5):3166-70. doi: 10.1167/iovs.13-11630.
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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.
Xuanchu Duan, Ph.D study director
Second Xiangya Hospital of Central South 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 Laserex Tango Nd:YAG, Ellex-SuperQ Medical, Australia in people with Primary Angle Closure Glaucoma, run by Second Xiangya Hospital of Central South 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 2 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 31 Oct 2014. 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 Haomin Luo, Ph.D student (+86 13875830738, lhmqqpp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in anterior chamber after LPI at 1 month (time frame: 1month). 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 NCT02279472, which also lists 2 linked publications.
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 31 Oct 2014.