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Dysphotopsia Following Laser Peripheral Iridotomy

Primary Purpose

Narrow Angle Patients at Risk for Angle Closure Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Neodymium-doped: Yttrium Aluminum Garnet (Nd:YAG) laser
Nd:YAG Laser Peripheral Iridotomy
Sponsored by
Credit Valley EyeCare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Narrow Angle Patients at Risk for Angle Closure Glaucoma focused on measuring Laser Peripheral Iridotomy, Visual Dysphotopsia, Visual Disturbances, Angle Closure Glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  • Able and willing to make the required study visit
  • Able and willing to give consent and follow study instructions
  • An indication to undergo laser peripheral iridotomy (narrow angles, occludeable angle at risk of acute angle closure, pupil block condition, chronic angle closure, pigment dispersion syndrome)

Exclusion Criteria:

  • Previous intraocular surgery
  • Best corrected visual acuity worse than 20/40
  • Asymmetrical ptosis of more than 2mm
  • Any active intraocular inflammation
  • Acute attack of angle closure glaucoma

Sites / Locations

  • Credit Valley EyeCare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Superior Laser Peripheral Iridotomy

Temporal Laser Peripheral Iridotomy

Arm Description

Neodymium-doped: Yttrium Aluminum Garnet (Nd:YAG) laser peripheral iridotomy was performed on the superior aspect of the iris in the eye being treated. This will be in the 11 to 1 o'clock position.

Neodymium-doped: Yttrium Aluminum Garnet (Nd:YAG) laser peripheral iridotomy was performed on the temporal aspect of the iris in the eye being treated. The position will be in the 2 to 4 o'clock in the left eye and 8 to 10 o'clock in the right eye.

Outcomes

Primary Outcome Measures

Presence of Linear Dysphotopsia
The change in presence of linear dysphotopsia from baseline (prior to intervention) to 1 month after the Nd:YAG laser intervention is performed.

Secondary Outcome Measures

Presence of Visual Dysphotopsia
This includes Halo, Crescent, Ghost Images, Glare, Shadows. This records the change in the presence of these symptoms from baseline (prior to intervention) and 1 month after the Nd:YAG laser intervention.
Pain Experienced
The pain experienced when the Nd:YAG procedure is performed. This is on a scale of 0-10 with 0 being no pain and 10 the most severe pain imaginable.
Nd:YAG Laser Power Used
The amount of laser power used on the Nd:YAG laser to perform the intervention.

Full Information

First Posted
December 20, 2012
Last Updated
February 11, 2013
Sponsor
Credit Valley EyeCare
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1. Study Identification

Unique Protocol Identification Number
NCT01758237
Brief Title
Dysphotopsia Following Laser Peripheral Iridotomy
Official Title
Incidence of Visual Symptom Following Laser (Nd:YAG ) Peripheral Iridotomy (LPI) in Relation to Position of LPI
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Credit Valley EyeCare

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To establish the correlation of the location of the Nd:YAG laser peripheral iridotomy to the post operative visual symptoms experienced by some patients. The investigators hypothesize that fully uncovered laser peripheral iridotomy will produce less significant dysphotopsia, due to avoidance of the prismatic effect produced by the tear film than those covered.
Detailed Description
Nd:YAG LPI is a frequently performed procedure for patients who have narrow angles at risk of acute angle closure glaucoma, pupillary-block conditions, chronic angle closure, and pigment dispersion syndrome. Most complications associated with the procedure are benign and include intraocular pressure (IOP) spike, transient uveitis, hyphema, corneal or lens damage and closure of the iridotomy. Visual disturbances have been also reported but only a few papers address this specific issue. The rate of these symptoms vary between 2.7% and 4%. It is believed that these symptoms are associated with the fact that light enters through the LPI and thus creating abnormal visual symptoms. Hence it has been suggested to carefully place the LPI so that the eyelid fully covers the LPI, therefore preventing light getting through. However, reports of patients with fully covered LPIs and visual disturbances have led to hypothesize the theory that even when fully covered by the eyelid, light can access through the LPI by a base-up prism created by the tear meniscus at the lid margin. Therefore, placement of the LPI, fully covered, partially covered or totally uncovered can potentially lead to equally significant symptoms. This study will attempt to address the issue of placement of the LPI in relationship with visual symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narrow Angle Patients at Risk for Angle Closure Glaucoma
Keywords
Laser Peripheral Iridotomy, Visual Dysphotopsia, Visual Disturbances, Angle Closure Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Superior Laser Peripheral Iridotomy
Arm Type
Experimental
Arm Description
Neodymium-doped: Yttrium Aluminum Garnet (Nd:YAG) laser peripheral iridotomy was performed on the superior aspect of the iris in the eye being treated. This will be in the 11 to 1 o'clock position.
Arm Title
Temporal Laser Peripheral Iridotomy
Arm Type
Experimental
Arm Description
Neodymium-doped: Yttrium Aluminum Garnet (Nd:YAG) laser peripheral iridotomy was performed on the temporal aspect of the iris in the eye being treated. The position will be in the 2 to 4 o'clock in the left eye and 8 to 10 o'clock in the right eye.
Intervention Type
Device
Intervention Name(s)
Neodymium-doped: Yttrium Aluminum Garnet (Nd:YAG) laser
Other Intervention Name(s)
Nd:YAG Laser
Intervention Description
This device is used to perform the peripheral iridotomy on all patients. It is a standard of care approved device.
Intervention Type
Procedure
Intervention Name(s)
Nd:YAG Laser Peripheral Iridotomy
Other Intervention Name(s)
Nd:YAG LPI
Intervention Description
After application of topical anesthetic to the eye undergoing the LPI, the patient is seated at the laser machine. Abraham iridotomy lens filled with a viscous material will be used to facilitate the procedure. The thinnest area of the iris quadrant treated will be chosen. Nd:YAG Laser will be applied until iridotomy is opened satisfactory.
Primary Outcome Measure Information:
Title
Presence of Linear Dysphotopsia
Description
The change in presence of linear dysphotopsia from baseline (prior to intervention) to 1 month after the Nd:YAG laser intervention is performed.
Time Frame
Baseline (Time =0),1 month
Secondary Outcome Measure Information:
Title
Presence of Visual Dysphotopsia
Description
This includes Halo, Crescent, Ghost Images, Glare, Shadows. This records the change in the presence of these symptoms from baseline (prior to intervention) and 1 month after the Nd:YAG laser intervention.
Time Frame
Baseline (Time = 0), 1 month
Title
Pain Experienced
Description
The pain experienced when the Nd:YAG procedure is performed. This is on a scale of 0-10 with 0 being no pain and 10 the most severe pain imaginable.
Time Frame
Procedure (Time = 0)
Title
Nd:YAG Laser Power Used
Description
The amount of laser power used on the Nd:YAG laser to perform the intervention.
Time Frame
Procedure (Time = 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able and willing to make the required study visit Able and willing to give consent and follow study instructions An indication to undergo laser peripheral iridotomy (narrow angles, occludeable angle at risk of acute angle closure, pupil block condition, chronic angle closure, pigment dispersion syndrome) Exclusion Criteria: Previous intraocular surgery Best corrected visual acuity worse than 20/40 Asymmetrical ptosis of more than 2mm Any active intraocular inflammation Acute attack of angle closure glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iqbal Ike K Ahmed, MD
Organizational Affiliation
University of Toronto, Toronto, Canada. University of Utah, Salt Lake City, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vanessa Vera, MD
Organizational Affiliation
University of Toronto, Canada
Official's Role
Study Director
Facility Information:
Facility Name
Credit Valley EyeCare
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5L 1W8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
6548087
Citation
Khodadoust AA, Arkfeld DF, Caprioli J, Sears ML. Ocular effect of neodymium-YAG laser. Am J Ophthalmol. 1984 Aug 15;98(2):144-52. doi: 10.1016/0002-9394(87)90348-5.
Results Reference
background
PubMed Identifier
1961641
Citation
Murphy PH, Trope GE. Monocular blurring. A complication of YAG laser iridotomy. Ophthalmology. 1991 Oct;98(10):1539-42. doi: 10.1016/s0161-6420(91)32091-8.
Results Reference
background
PubMed Identifier
16148584
Citation
Spaeth GL, Idowu O, Seligsohn A, Henderer J, Fonatanarosa J, Modi A, Nallamshetty HS, Chieh J, Haim L, Steinmann WC, Moster M. The effects of iridotomy size and position on symptoms following laser peripheral iridotomy. J Glaucoma. 2005 Oct;14(5):364-7. doi: 10.1097/01.ijg.0000177213.31620.02.
Results Reference
background
PubMed Identifier
1584561
Citation
Weintraub J, Berke SJ. Blurring after iridotomy. Ophthalmology. 1992 Apr;99(4):479-80. doi: 10.1016/s0161-6420(92)38516-1. No abstract available.
Results Reference
background
PubMed Identifier
22424576
Citation
Congdon N, Yan X, Friedman DS, Foster PJ, van den Berg TJ, Peng M, Gangwani R, He M. Visual symptoms and retinal straylight after laser peripheral iridotomy: the Zhongshan Angle-Closure Prevention Trial. Ophthalmology. 2012 Jul;119(7):1375-82. doi: 10.1016/j.ophtha.2012.01.015. Epub 2012 Mar 14.
Results Reference
background
PubMed Identifier
16228219
Citation
Chung RS, Guan AE. Unusual visual disturbance following laser peripheral iridotomy for intermittent angle closure glaucoma. Graefes Arch Clin Exp Ophthalmol. 2006 Apr;244(4):532-3. doi: 10.1007/s00417-005-0129-x. Epub 2005 Oct 14. No abstract available.
Results Reference
background
PubMed Identifier
24531024
Citation
Vera V, Naqi A, Belovay GW, Varma DK, Ahmed II. Dysphotopsia after temporal versus superior laser peripheral iridotomy: a prospective randomized paired eye trial. Am J Ophthalmol. 2014 May;157(5):929-35. doi: 10.1016/j.ajo.2014.02.010. Epub 2014 Feb 14.
Results Reference
derived

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Dysphotopsia Following Laser Peripheral Iridotomy

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