Comparing Nd:YAG Laser and Sequential Double Frequency YAG-Nd:YAG Laser Iridotomy
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
1 other identifier
interventional
82
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 11, 2015
CompletedFirst Posted
Study publicly available on registry
June 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedAugust 27, 2018
August 1, 2018
3.3 years
June 11, 2015
August 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Laser energy
Total energy used to create patency on the iris
1-hour
Secondary Outcomes (5)
Bleeding
1-hour
Corneal endothelial cell count
12-month
Central corneal thickness
12-month
Patency of iridotomy
12-month
Intraocular pressure spike
1-hour
Study Arms (2)
The sequential technique
EXPERIMENTALBy 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 COMPARATORBy using the pure Nd:YAG to make a complete perforation on iris.
Interventions
By using 'the double frequency YAG laser' to make the initial bore and 'the Nd:YAG laser' to complete the perforation on iris.
By using 'the pure Nd:YAG laser' to make a complete perforation on iris.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weerawat Kiddee
Hat Yai, Changwat Songkhla, 90110, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asst.Prof.Weerawat Kiddee, MD
Prince of Songkla University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asst.Prof.Weerawat Kiddee
Study Record Dates
First Submitted
June 11, 2015
First Posted
June 17, 2015
Study Start
May 1, 2015
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
August 27, 2018
Record last verified: 2018-08