Angle Closure GlaucomaNCT02474238
Comparing Nd:YAG Laser and Sequential Double Frequency YAG-Nd:YAG Laser Iridotomy
A study testing The sequential technique and The pure Nd:YAG laser technique in people with Angle Closure Glaucoma, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
No single type of laser or set of laser parameters is appropriate for all type of irides. Pure Nd:YAG laser iridotomy is very effective in the light color irides. It was considered as the gold standard for iridotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angle Closure Glaucoma
- What is being tested?
- The sequential technique and The pure Nd:YAG laser technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteThailand
- Study dates
- May 2015to Aug 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient in need to have a laser iridotomy
- primary angle closure glaucoma or
- primary angle closure or
- primary angle closure suspect (needed repeated pupil dilation) or
- fellow eyes of acute angle closure crisis, and
- Age of at least 18 years, and
- Dark iris patients (only black and dark brown color)
Who cannot join
- Eye with acute angle closure crisis
- Active conjunctiva or corneal infection or inflammation
- Active anterior uveitis
- History of any prior laser treatment
- History intraocular surgery
- Eye with corneal scar
Show all 10Show fewer
- Corneal haziness obscure iridotomy site
- Endothelial cell count less than 1000 cells/mm2 (pre-laser)
- Iris color other than black or dark brown
- Inability to sit at the slit lamp to have laser done
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial Comparing Neodynium:Ytrium-aluminium-garnet (Nd:YAG) Laser and Sequential Double Frequency YAG-Nd:YAG Laser Iridotomy in Patients With Dark Iris
No single type of laser or set of laser parameters is appropriate for all type of irides. Pure Nd:YAG laser iridotomy is very effective in the light color irides. It was considered as the gold standard for iridotomy. It, however, is less effective and causes some complication such as iris hemorrhage especially in patients with dark iris.
Read the detailed description
By using the double frequency YAG to make the initial bore and the Nd:YAG laser to complete the perforation, the technique should be able to effectively combine most of the advantages of both lasers whilst avoiding their disadvantages. It is possibly the ideal iridotomy technique to use in the Asian irides. The investigators aim to study the energy use for laser iridotomy comparing between the two techniques as well as objectively measure the variables associated with complications.
- Conditions
- Angle Closure Glaucoma
- Being tested
- The sequential technique, The pure Nd:YAG laser technique
- Keywords
- Iridotomy
- 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.
The sequential techniqueDevice
By using 'the double frequency YAG laser' to make the initial bore and 'the Nd:YAG laser' to complete the perforation on iris.
The pure Nd:YAG laser techniqueDevice
By using 'the pure Nd:YAG laser' to make a complete perforation on iris.
| Study group | Role | What they receive |
|---|---|---|
| The sequential technique | Experimental | By using the double frequency YAG laser to make the initial bore and the Nd:YAG laser to complete the perforation on iris. Receives: Device: The sequential technique |
| The pure Nd:YAG laser technique | Active comparator | By using the pure Nd:YAG to make a complete perforation on iris. Receives: Device: The pure Nd:YAG laser technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laser energy
Total energy used to create patency on the iris
Measured: 1-hour
Secondary outcomes (5)
Bleeding
iris bleeding immediate after laser reported as Yes or No
Measured: 1-hour
Corneal endothelial cell count
Corneal endothelial cell count directly over the area of laser
Measured: 12-month
Central corneal thickness
Central corneal thickness
Measured: 12-month
Patency of iridotomy
Iridotomy patency is confirmed objectively reported as yes or no
Measured: 12-month
Intraocular pressure spike
Intraocular pressure spike if present mean that IOP evelation of at least 8mmHg from baseline intraocular pressure
Measured: 1-hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angle Closure GlaucomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weerawat Kiddee, Prince of Songkla University
- Investigators
- Asst.Prof.Weerawat Kiddee, MD, Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474238
- Sponsor's protocol ID
- EC-58-093-02-1
- Status last verified
- Aug 2018
- First submitted
- 11 Jun 2015
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Neodynium:Ytrium-aluminium-garnet (Nd:YAG) Laser and Sequential Double Frequency YAG-Nd:YAG Laser Iridotomy in Patients With Dark Iris
- ClinicalTrials.gov ID
- NCT02474238
- Acronym / sponsor ID
- EC-58-093-02-1
- Conditions
- Angle Closure Glaucoma
- Keywords
- Iridotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 17 Jun 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.
No single type of laser or set of laser parameters is appropriate for all type of irides. Pure Nd:YAG laser iridotomy is very effective in the light color irides. It was considered as the gold standard for iridotomy. It, however, is less effective and causes some complication such as iris hemorrhage especially in patients with dark iris.
Detailed description
By using the double frequency YAG to make the initial bore and the Nd:YAG laser to complete the perforation, the technique should be able to effectively combine most of the advantages of both lasers whilst avoiding their disadvantages. It is possibly the ideal iridotomy technique to use in the Asian irides. The investigators aim to study the energy use for laser iridotomy comparing between the two techniques as well as objectively measure the variables associated with complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The sequential technique | Experimental | Device: The sequential techniqueBy using the double frequency YAG laser to make the initial bore and the Nd:YAG laser to complete the perforation on iris. |
| The pure Nd:YAG laser technique | Active comparator | Device: The pure Nd:YAG laser techniqueBy using the pure Nd:YAG to make a complete perforation on iris. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient in need to have a laser iridotomy
- Age of at least 18 years, and
- Dark iris patients (only black and dark brown color)
Key exclusion criteria (10 listed)
- Eye with acute angle closure crisis
- Active conjunctiva or corneal infection or inflammation
- Active anterior uveitis
- History of any prior laser treatment
- History intraocular surgery
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 |
|---|---|---|
| The sequential techniqueBy using 'the double frequency YAG laser' to make the initial bore and 'the Nd:YAG laser' to complete the perforation on iris. | Device | The sequential technique |
| The pure Nd:YAG laser techniqueBy using 'the pure Nd:YAG laser' to make a complete perforation on iris. | Device | The pure Nd:YAG laser technique |
Primary outcome
Laser energy
Time frame: 1-hour
Total energy used to create patency on the iris
5 secondary outcomes
Bleeding
Time frame: 1-hour
Corneal endothelial cell count
Time frame: 12-month
Central corneal thickness
Time frame: 12-month
Patency of iridotomy
Time frame: 12-month
Intraocular pressure spike
Time frame: 1-hour
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 27 Aug 2018.
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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.
Asst.Prof.Weerawat Kiddee, MD principal investigator
Prince of Songkla 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 The sequential technique and The pure Nd:YAG laser technique in people with Angle Closure Glaucoma, run by Prince of Songkla 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 7 inclusion and 10 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 27 Aug 2018. 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.
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?
Laser energy (time frame: 1-hour). 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 27 Aug 2018.