Back to results

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

Primary Purpose

Angle Closure Glaucoma

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

The sequential technique

The pure Nd:YAG laser technique

About this trial

This is an interventional treatment trial for Angle Closure Glaucoma focused on measuring Iridotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Weerawat Kiddee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The sequential technique

The pure Nd:YAG laser technique

Arm Description

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 to make a complete perforation on iris.

Outcomes

Primary Outcome Measures

Laser energy

Total energy used to create patency on the iris

Secondary Outcome Measures

Bleeding

iris bleeding immediate after laser reported as Yes or No

Corneal endothelial cell count

Corneal endothelial cell count directly over the area of laser

Central corneal thickness

Patency of iridotomy

Iridotomy patency is confirmed objectively reported as yes or no

Intraocular pressure spike

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

Full Information

NCT ID

NCT02474238

First Posted

June 11, 2015

Last Updated

August 24, 2018

Sponsor

Prince of Songkla University

1. Study Identification

Unique Protocol Identification Number

NCT02474238

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

August 2018 (Actual)

Study Completion Date

August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Prince of Songkla University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Angle Closure Glaucoma

Keywords

Iridotomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

The sequential technique

Arm Type

Experimental

Arm Description

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

Arm Title

The pure Nd:YAG laser technique

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

The sequential technique

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

The pure Nd:YAG laser technique

Intervention Description

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

Primary Outcome Measure Information:

Title

Laser energy

Description

Total energy used to create patency on the iris

Time Frame

1-hour

Secondary Outcome Measure Information:

Title

Bleeding

Description

iris bleeding immediate after laser reported as Yes or No

Time Frame

1-hour

Title

Corneal endothelial cell count

Description

Corneal endothelial cell count directly over the area of laser

Time Frame

12-month

Title

Central corneal thickness

Description

Central corneal thickness

Time Frame

12-month

Title

Patency of iridotomy

Description

Iridotomy patency is confirmed objectively reported as yes or no

Time Frame

12-month

Title

Intraocular pressure spike

Description

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

Time Frame

1-hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Asst.Prof.Weerawat Kiddee, MD

Organizational Affiliation

Prince of Songkla University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weerawat Kiddee

City

Hat Yai

State/Province

Songkhla

ZIP/Postal Code

90110

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs