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OpenTrials
Completed

NCT Number: NCT01758237

Dysphotopsia Following Laser Peripheral Iridotomy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Credit Valley EyeCare

Mississauga, Ontario, L5L 1W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neodymium-doped: Yttrium Aluminum Garnet (Nd:YAG) laser

Device

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

Nd:YAG Laser Peripheral Iridotomy

Procedure

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

Primary outcomes

  1. Presence of Linear Dysphotopsia

    Time frame: 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 outcomes

  1. Presence of Visual Dysphotopsia

    Time frame: 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

    Time frame: 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

    Time frame: Procedure (Time = 0)

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

Sponsors and collaborators

Lead sponsor

Credit Valley EyeCare

Industry

Registry information

Official study title

Incidence of Visual Symptom Following Laser (Nd:YAG ) Peripheral Iridotomy (LPI) in Relation to Position of LPI

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 1, 2013
Registry last updated
Feb 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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