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Chronic Angle Closure GlaucomaNCT00452998

Sequential Laser Iridotomy Using Argon and Q-Switched 532 nm Frequency Doubled Neodymium Yag Laser: A Pilot Study

A study testing Q-switched fd Nd:yag in Laser Iridotomy in people with Chronic Angle Closure Glaucoma and Primary Angle Closure, run by National University Hospital, Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Sequential Laser Iridotomy uses argon and Nd:yag laser in the first and second steps, respectively. Using q-switched 532 nm laser in the second step is hypothesized to be as good and effective as the conventional Nd:yag laser, because it selectively targets pigmented cells and delivers a short pulse duration of 3… Read more about this study

Who is it for?
Ages 22 years and olderHealthy volunteers can take part
What is being tested?
Q-switched fd Nd:yag in Laser Iridotomy
Type of treatment
Surgery or procedure
How many people
10 participants
Where
1 siteSingapore
Study dates
Nov 2006to Dec 2007
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 22 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • More than 21 years old
  • Able to give informed consent
  • Diagnosis of either: chronic angle closure glaucoma (CACG), primary angle closure (PAC), primary angle closure suspect (PACS) or fellow eyes of acute angle closure glaucoma (AACG), and in need of a laser iridotomy

Who cannot join

  • History of any prior laser treatment or intraocular surgery to the eye
  • History of any corneal disease
  • Any ocular infection/ inflammation within the last two months
  • Inability to give informed consent

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • National University Hospital

    Singapore, 119074

Other trials in Singapore

About this study

Sequential Laser Iridotomy uses argon and Nd:yag laser in the first and second steps, respectively. Using q-switched 532 nm laser in the second step is hypothesized to be as good and effective as the conventional Nd:yag laser, because it selectively targets pigmented cells and delivers a short pulse duration of 3 nanoseconds, causing less thermal and collateral damage.

Read the detailed description

Laser iridotomy is an established procedure in the management of angle closure glaucoma (ACG) and for prophylaxis in the fellow eyes.

Sequential argon-YAG (SAY) laser iridotomy is the serial use of argon and Nd:YAG laser at the same treatment session to create an iridotomy. Argon laser is initially used to make a bore of about 500 μm in diameter to an estimated two-thirds iris thickness in depth. The 1064 nm Q-switched neodymium YAG laser is next used to complete the perforation1. Others aim the argon laser at the iris surface to create a crater, and the next shots at the base of the crater until the iris is penetrated as evidenced by a pigment plume. The Nd:YAG laser then creates a photodisruptive explosion to enlarge the opening.

This procedure was first described by Zborwski-Gutman in 1988. Sixteen eyes were treated with two argon stretch burns and up to 35 penetrating burns that produced an iridotomy that was either imperforate or inadequate. Nd:YAG laser was used to complete the iridotomy. In all the eyes, the iridotomy was achieved in one session, and two eyes had a moderate increase in pressure that was easily controlled. The authors found that the total energy levels for each laser modality were significantly lower than those previously reported using either laser alone. The authors concluded that the sequential technique is safe and effective, and is recommended for iridotomy in difficult iris types.

Lim et al in 1996 did a prospective study that compared argon laser iridotomy and SAY in dark irides. Twenty-four eyes of 17 patients were involved; and 13 underwent argon laser iridotomies, and 11 underwent SAY. The argon laser settings were standardized at 1.2 W, 50 μm spot size and 0.1 second duration. The Nd: YAG laser was set at 2.5 mJ and single-pulse shots were used. All the iridotomies were completed in a single session. The mean total energy used for argon laser iridotomy was 8.28 J; while for SAY, 3.12 J was used for the argon laser stage and 7.5 mJ for the Nd:YAG stage. The authors concluded that the total argon laser energy used can be reduced by 2.65 times using the SAY technique.

The SAY technique is ideal in Asian eyes because it avoids the disadvantages of argon and Nd-YAG laser, when they are used as separate methods.

In SAY, bleeding is uncommon and microscopic, unlike in Nd:YAG iridotomy wherein it can be severe enough to cause the abortion of the procedure. Nd:YAG iridotomy is rarely associated with focal lens or retina damage; but argon laser can cause inadvertent focal lens damage.

By using ND:YAG laser as second stage laser, SAY iridotomy avoids the tedious and hazardous chipping enlargement phase of argon iridotomy that can contribute to retinal damage. Likewise, with the argon laser pre-treatment, excessive pigment and debris dispersion, iris splintering, and high energy levels needed for iris perforation from a Nd:YAG iridotomy in an Asian eye is avoided. In Ho's series of 20 patients who underwent SAY, only one eye had iridotomy closure during a mean follow-up period of 14 months.

Q-switched 532 nm frequency-doubled neodymium:yytrium-aluminum-garnet (fd-Nd:YAG) laser has been used in the recent years for selective laser trabeculoplasty (SLT). It was developed by Latina et.al. to selectively target pigmented trabecular meshwork (TM) cells without causing thermal or collateral damage to the nonpigmented cells or structures of the TM. This is so because it is able to deliver a short pulse duration of 3 nanoseconds while selectively lysing intracellular melanosomes, killing pigmented cells and leaving cellular membranes and neighboring nonpigmented cells intact. This technique delivers less than 1% of the energy of ALT, with shorter pulse durations and consequently higher power levels. Latina noted bubble formation at higher fluence, but this is not from boiling tissue, but are microcellular cavitation effects.

Being tested
Q-switched fd Nd:yag in Laser Iridotomy
Keywords
Sequential Laser Iridotomy, Q-Switched 532 nm Laser, Frequency Doubled Neodymium Yag Laser

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Q-switched fd Nd:yag in Laser IridotomyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Acuity

  2. Intraocular pressure

  3. Total power delivered by each laser modality

  4. Iridotomy patency and size

  5. Pain rating during the procedure

  6. Anterior segment inflammation

  7. Endothelial cell count

  8. Cataract progression

  9. Rate of complications

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2007 (estimated)
  2. Study startNov 2006
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00452998
Sponsor's protocol ID
DSRB A/06/293
Status last verified
May 2008
First submitted
27 Mar 2007
Last updated
14 May 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Latina MA, Park C. Selective targeting of trabecular meshwork cells: in vitro studies of pulsed and CW laser interactions. Exp Eye Res. 1995 Apr;60(4):359-71. doi: 10.1016/s0014-4835(05)80093-4.

    PubMed 7789416

Questions about this trial

What is this clinical trial studying?

A study testing Q-switched fd Nd:yag in Laser Iridotomy in people with Chronic Angle Closure Glaucoma and Primary Angle Closure, run by National University Hospital, Singapore at 1 site in Singapore.

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 4 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 14 May 2008. 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 Singapore. 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?

Visual Acuity. The study lists 9 primary outcomes in all. 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 NCT00452998, which also lists 1 linked publication.

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 14 May 2008; AzTrials last refreshed its copy on 31 Oct 2026.

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