Dysphotopsia Following Laser Peripheral Iridotomy

Sponsor
Credit Valley EyeCare (Industry)
Overall Status
Completed
CT.gov ID
NCT01758237
Collaborator
(none)
214
1
2
12
17.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Neodymium-doped: Yttrium Aluminum Garnet (Nd:YAG) laser
  • Procedure: Nd:YAG Laser Peripheral Iridotomy
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
214 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Incidence of Visual Symptom Following Laser (Nd:YAG ) Peripheral Iridotomy (LPI) in Relation to Position of LPI
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Jan 1, 2009
Actual Study Completion Date :
Jan 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Superior Laser Peripheral Iridotomy

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.

Device: Neodymium-doped: Yttrium Aluminum Garnet (Nd:YAG) laser
This device is used to perform the peripheral iridotomy on all patients. It is a standard of care approved device.
Other Names:
  • Nd:YAG Laser
  • Procedure: Nd:YAG Laser Peripheral Iridotomy
    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.
    Other Names:
  • Nd:YAG LPI
  • Experimental: Temporal Laser Peripheral Iridotomy

    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.

    Device: Neodymium-doped: Yttrium Aluminum Garnet (Nd:YAG) laser
    This device is used to perform the peripheral iridotomy on all patients. It is a standard of care approved device.
    Other Names:
  • Nd:YAG Laser
  • Procedure: Nd:YAG Laser Peripheral Iridotomy
    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.
    Other Names:
  • Nd:YAG LPI
  • Outcome Measures

    Primary Outcome Measures

    1. Presence of Linear Dysphotopsia [Baseline (Time =0),1 month]

      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

    1. Presence of Visual Dysphotopsia [Baseline (Time = 0), 1 month]

      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.

    2. Pain Experienced [Procedure (Time = 0)]

      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.

    3. Nd:YAG Laser Power Used [Procedure (Time = 0)]

      The amount of laser power used on the Nd:YAG laser to perform the intervention.

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Credit Valley EyeCare Mississauga Ontario Canada L5L 1W8

    Sponsors and Collaborators

    • Credit Valley EyeCare

    Investigators

    • Principal Investigator: Iqbal Ike K Ahmed, MD, University of Toronto, Toronto, Canada. University of Utah, Salt Lake City, USA
    • Study Director: Vanessa Vera, MD, University of Toronto, Canada

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Iqbal Ike Ahmed, Principle Investigator, Credit Valley EyeCare
    ClinicalTrials.gov Identifier:
    NCT01758237
    Other Study ID Numbers:
    • CVEC-LPI
    First Posted:
    Jan 1, 2013
    Last Update Posted:
    Feb 13, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Iqbal Ike Ahmed, Principle Investigator, Credit Valley EyeCare
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 13, 2013