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Completed

NCT Number: NCT02474238

Comparing Nd:YAG Laser and Sequential Double Frequency YAG-Nd:YAG Laser Iridotomy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weerawat Kiddee

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • 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

Treatment and study plan

The sequential technique

Device

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 technique

Device

By using 'the pure Nd:YAG laser' to make a complete perforation on iris.

Primary outcomes

  1. Laser energy

    Time frame: 1-hour

    Total energy used to create patency on the iris

Secondary outcomes

  1. Bleeding

    Time frame: 1-hour

    iris bleeding immediate after laser reported as Yes or No

  2. Corneal endothelial cell count

    Time frame: 12-month

    Corneal endothelial cell count directly over the area of laser

  3. Central corneal thickness

    Time frame: 12-month

    Central corneal thickness

  4. Patency of iridotomy

    Time frame: 12-month

    Iridotomy patency is confirmed objectively reported as yes or no

  5. Intraocular pressure spike

    Time frame: 1-hour

    Intraocular pressure spike if present mean that IOP evelation of at least 8mmHg from baseline intraocular pressure

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 17, 2015
Registry last updated
Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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