Dysphotopsia Following Laser Peripheral Iridotomy

NCT ID: NCT01758237

Last Updated: 2013-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-01-31

Brief Summary

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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

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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.

Conditions

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Narrow Angle Patients at Risk for Angle Closure Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

This device is used to perform the peripheral iridotomy on all patients. It is a standard of care approved device.

Nd:YAG Laser Peripheral Iridotomy

Intervention Type 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.

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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

This device is used to perform the peripheral iridotomy on all patients. It is a standard of care approved device.

Nd:YAG Laser Peripheral Iridotomy

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Other Intervention Names

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Nd:YAG Laser Nd:YAG LPI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Credit Valley EyeCare

INDUSTRY

Sponsor Role lead

Responsible Party

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Iqbal Ike Ahmed

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iqbal Ike K Ahmed, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto, Toronto, Canada. University of Utah, Salt Lake City, USA

Vanessa Vera, MD

Role: STUDY_DIRECTOR

University of Toronto, Canada

Locations

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Credit Valley EyeCare

Mississauga, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 6548087 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1961641 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16148584 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1584561 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22424576 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16228219 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24531024 (View on PubMed)

Other Identifiers

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CVEC-LPI

Identifier Type: -

Identifier Source: org_study_id

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