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Angle Closure GlaucomaALPIECANCT02199158

Short-term Outcomes of Iridoplasty for Persistent Angle Closure Despite Patent Iridotomies

A study testing Argon Laser Peripheral Iridoplasty in people with Angle Closure Glaucoma and Glaucoma, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Angle Closure Glaucoma, Glaucoma
What is being tested?
Argon Laser Peripheral Iridoplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteMexico
Study dates
Jul 2012to Jan 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • "Fundación Conde de Valenciana" Ophthalmology Institute

    Mexico City, Obrera, 06800

Other trials in Mexico

About this study

Official title: Short-term Outcomes of Iridoplasty for Persistent Angle Closure Despite Patent Iridotomies An Anterior Segment Optical Coherence Tomography Study

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.

Read more

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.

Read the detailed description

Background Argon laser peripheral iridoplasty (ALPI) (Figure 1) is an iris-remodeling procedure that intends to widen the iridocorneal angle through redistribution of peripheral iris tension forces close to the trabeculum.

ALPI is effective in patients with plateau iris syndrome and acute angle closure glaucoma but there is less published about its effectiveness in secondary angle closure. Therefore, we are going to evaluate this procedure in those patients that did not achieve a satisfactory clinical angle opening despite patent laser peripheral iridotomy, as long as there was no contraindication for a new laser procedure and provided that cataract surgery is not viable, as in clear lens or patients not willing to undergo surgery.

To evaluate its effectiveness, we will use a non-invasive non-contact method through anterior segment optical coherence tomography (AS-OCT), which transmits and receives light in an ultrasound-like manner to obtain anterior segment imaging that helps to evaluate the angle more objectively.

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 with persistent angle closure despite patent iridotomies.

Study Design Prospective, interventional case series 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 will be obtained. Patients who presented with these criteria to the angle closure clinic at the glaucoma service of our institute (Instituto de Oftalmologia Fundacion Conde de Valenciana IAP, Mexico City) between July and November 2012 were included.

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.

After obtaining informed consent, patients underwent biomicroscopy, gonioscopy, visual acuity, intraocular pressure and AS-OCT before ALPI, one week and one month after it. The AS-OCT Visante (Carl Zeiss Meditec, Dublin) took an image of the vertical and horizontal meridians at the same room illumination of 14 lux measured with a luxometer mobile application (Apple Inc., Application Manufactory available at the AppStore by June 2012).

Images were analyzed in a masked manner marking scleral spurs and angle recess at 0° and 180° of the horizontal image.

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. Pilocarpine was not applied before the procedure in all cases because some eyes had angle closure secondary to ciliary block and we considered it could worsen the closure in many cases.

Topical prednisolone acetate was applied every 4 hours for 1 week and brimonidine tartrate every 12 hours for 1 week .

Being tested
Argon Laser Peripheral Iridoplasty
Keywords
iridoplasty, angle, glaucoma, anterior chamber, laser treatment
Medical subject headings
Glaucoma, Angle-Closure, Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Argon Laser Peripheral IridoplastyProcedure or surgery

    Also called ALPI, Iridoplasty

    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.

Study groups in NCT02199158
Study groupRoleWhat they receive
Argon Laser Peripheral IridoplastyExperimentalALPI 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.
Receives: Procedure: Argon Laser Peripheral Iridoplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Angle Aperture

    Angle opening measured by anterior segment optical coherence tomography

    Measured: 1 month

Secondary outcomes (1)
  1. Complications

    complications reported by patient and/or examiner

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2014 (estimated)
  2. Study startJul 2012
  3. Primary completionNov 2012
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02199158
Sponsor's protocol ID
iridoplastiaeca
Acronym
ALPIECA
Status last verified
Jul 2014
First submitted
14 Jul 2014
Last updated
24 Jul 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17472803
  • 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.

    PubMed 14711720
  • 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.

    PubMed 23286475

Questions about this trial

What is this clinical trial studying?

A study testing Argon Laser Peripheral Iridoplasty in people with Angle Closure Glaucoma and Glaucoma, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Angle Aperture (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02199158, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.

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