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Dysphotopsia Following Laser Peripheral Iridotomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01758237
Enrollment
214
Registered
2013-01-01
Start date
2008-01-31
Completion date
2009-01-31
Last updated
2013-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narrow Angle Patients at Risk for Angle Closure Glaucoma

Keywords

Laser Peripheral Iridotomy, Visual Dysphotopsia, Visual Disturbances, Angle Closure Glaucoma

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.

Interventions

DEVICENeodymium-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.

PROCEDURENd: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.

Sponsors

Credit Valley EyeCare
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Presence of Linear DysphotopsiaBaseline (Time =0),1 monthThe change in presence of linear dysphotopsia from baseline (prior to intervention) to 1 month after the Nd:YAG laser intervention is performed.

Secondary

MeasureTime frameDescription
Presence of Visual DysphotopsiaBaseline (Time = 0), 1 monthThis 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 ExperiencedProcedure (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.
Nd:YAG Laser Power UsedProcedure (Time = 0)The amount of laser power used on the Nd:YAG laser to perform the intervention.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026