NCT02199158

Brief Summary

Purpose: To evaluate short-term angle opening after argon peripheral iridoplasty using AS-OCT and to report its complications at 1-week and 1-month follow up in patients that did not achieve a satisfactory clinical angle opening despite patent laser peripheral iridotomy. Design: Prospective, Interventional case series Subjects: Patients with an occludable angle in more than two quadrants in dark room indentation gonioscopy and patent iridotomies of at least 2 weeks, with assessment of persistent angle closure aetiology by ultrabiomicroscopy and A-scan ultrasound are included. Patients will undergo complete examination and AS-OCT before ALPI, one week and one month after it. We analyzed the images in a masked manner and took the angle measurements (AOD500, AOD 750, TISA500, TISA750, ARA500, ARA 750, Lens vault) at 0° and 180° as the main outcome measure to determine effectiveness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

4 months

First QC Date

July 14, 2014

Last Update Submit

July 22, 2014

Conditions

Keywords

iridoplastyangleglaucomaanterior chamberlaser treatment

Outcome Measures

Primary Outcomes (1)

  • Angle Aperture

    Angle opening measured by anterior segment optical coherence tomography

    1 month

Secondary Outcomes (1)

  • Complications

    1 month

Study Arms (1)

Argon Laser Peripheral Iridoplasty

EXPERIMENTAL

ALPI was applied with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA) by the same ophthalmologist (JML). Twenty to 40 spots of 400 mW power with 500 microns of size and duration of 500 ms were applied. Power was modified arbitrarily until an effective iris contraction was obtained. It was considered an effective contraction as that which causes a concentric movement around the laser spot, with minimal iris pigmentation and immediate angle opening observed through the lens mirrors using a Goldmann lens. Power was lowered if there was any bursting sound perceived, pigment dispersion, air bubbles or considerable pain.

Procedure: Argon Laser Peripheral Iridoplasty

Interventions

ALPI was applied with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA) by the same ophthalmologist (JML). Twenty to 40 spots of 400 mW power with 500 microns of size and duration of 500 ms were applied. Power was modified arbitrarily until an effective iris contraction was obtained. It was considered an effective contraction as that which causes a concentric movement around the laser spot, with minimal iris pigmentation and immediate angle opening observed through the lens mirrors using a Goldmann lens. Power was lowered if there was any bursting sound perceived, pigment dispersion, air bubbles or considerable pain.

Also known as: ALPI, Iridoplasty
Argon Laser Peripheral Iridoplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with an occludable angle in more than two quadrants in dark room dynamic gonioscopy and patent iridotomies of at least 2 weeks were included
  • A supplemental diagnosis regarding the etiology of persistent angle closure by ultrabiomicroscopy and A-scan ultrasound was obtained.

You may not qualify if:

  • Patients with synechiae of more than one quadrant
  • Advanced glaucomatous damage
  • Prompt cataract surgery plans and those who did not wish to participate were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Fundación Conde de Valenciana" Ophthalmology Institute

Mexico City, Obrera, 06800, Mexico

Location

Related Publications (3)

  • Ritch R, Tham CC, Lam DS. Argon laser peripheral iridoplasty (ALPI): an update. Surv Ophthalmol. 2007 May-Jun;52(3):279-88. doi: 10.1016/j.survophthal.2007.02.006.

    PMID: 17472803BACKGROUND
  • Ritch R, Tham CC, Lam DS. Long-term success of argon laser peripheral iridoplasty in the management of plateau iris syndrome. Ophthalmology. 2004 Jan;111(1):104-8. doi: 10.1016/j.ophtha.2003.05.001.

    PMID: 14711720BACKGROUND
  • Fu J, Qing GP, Wang NL, Wang HZ. Efficacy of laser peripheral iridoplasty and iridotomy on medically refractory patients with acute primary angle closure: a three year outcome. Chin Med J (Engl). 2013 Jan;126(1):41-5.

    PMID: 23286475BACKGROUND

MeSH Terms

Conditions

Glaucoma, Angle-ClosureGlaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Jorge-Emmanuel Morales-León, MD

    "Fundación Conde de Valenciana" Ophthalmology Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2014

First Posted

July 24, 2014

Study Start

July 1, 2012

Primary Completion

November 1, 2012

Study Completion

January 1, 2013

Last Updated

July 24, 2014

Record last verified: 2014-07

Locations