Short-term Outcomes of Iridoplasty for Persistent Angle Closure Despite Patent Iridotomies
ALPIECA
1 other identifier
interventional
10
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 14, 2014
CompletedFirst Posted
Study publicly available on registry
July 24, 2014
CompletedJuly 24, 2014
July 1, 2014
4 months
July 14, 2014
July 22, 2014
Conditions
Keywords
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
EXPERIMENTALALPI 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.
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.
Eligibility Criteria
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
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: 17472803BACKGROUNDRitch 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: 14711720BACKGROUNDFu 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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jorge-Emmanuel Morales-León, MD
"Fundación Conde de Valenciana" Ophthalmology Institute
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