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

Sponsor
Prince of Songkla University (Other)
Overall Status
Completed
CT.gov ID
NCT02474238
Collaborator
(none)
82
1
2
39
2.1

Study Details

Study Description

Brief 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. It, however, is less effective and causes some complication such as iris hemorrhage especially in patients with dark iris.

Condition or Disease Intervention/Treatment Phase
  • Device: The sequential technique
  • Device: The pure Nd:YAG laser technique
N/A

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

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Aug 1, 2018
Actual Study Completion Date :
Aug 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: The sequential technique

By 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
By using 'the double frequency YAG laser' to make the initial bore and 'the Nd:YAG laser' to complete the perforation on iris.

Active Comparator: The pure Nd:YAG laser technique

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

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

Outcome Measures

Primary Outcome Measures

  1. Laser energy [1-hour]

    Total energy used to create patency on the iris

Secondary Outcome Measures

  1. Bleeding [1-hour]

    iris bleeding immediate after laser reported as Yes or No

  2. Corneal endothelial cell count [12-month]

    Corneal endothelial cell count directly over the area of laser

  3. Central corneal thickness [12-month]

    Central corneal thickness

  4. Patency of iridotomy [12-month]

    Iridotomy patency is confirmed objectively reported as yes or no

  5. Intraocular pressure spike [1-hour]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Weerawat Kiddee Hat Yai Songkhla Thailand 90110

Sponsors and Collaborators

  • Prince of Songkla University

Investigators

  • Principal Investigator: Asst.Prof.Weerawat Kiddee, MD, Prince of Songkla University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weerawat Kiddee, Asst.Prof.Weerawat Kiddee, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT02474238
Other Study ID Numbers:
  • EC-58-093-02-1
First Posted:
Jun 17, 2015
Last Update Posted:
Aug 27, 2018
Last Verified:
Aug 1, 2018
Keywords provided by Weerawat Kiddee, Asst.Prof.Weerawat Kiddee, Prince of Songkla University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 27, 2018