NCT02870504

Brief Summary

Glaucoma is the second cause of blindness worldwide. Laser peripheral iridoplasty (LPI) is a simple and effective treatment for angle closure glaucoma. LPI can widen or reopen an existing angle close or angle adhesion in order to reduce the risk of attack of the angle closure glaucoma. However, there are very little research on the laser site, laser wavelengths, laser energy and laser spot intervals. The purpose of this study is to determine the optimum laser site of LPI.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Status
unknown

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, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

1.4 years

First QC Date

August 10, 2016

Last Update Submit

September 11, 2016

Conditions

Glaucoma

Keywords

laser peripheral iridoplastytreatment

Outcome Measures

Primary Outcomes (1)

  • Change of anterior chamber angle(AA)

    Anterior chamber angle (AA) is measured with ultrasound biomicroscopy.

    Baseline and 3 months after LPI

Secondary Outcomes (9)

  • Change of anterior chamber angle opening distance 750(AOD750)

    Baseline and 3 months after LPI

  • Change of anterior chamber depth(ACD)

    Baseline and 3 months after LPI.

  • Change of intraocular pressure (IOP)

    Baseline and 1hour, 1days, 3day, 7days, 1 month, 3 months after LPI.

  • Change of C value

    Baseline and 7days, 1 month, 3 months after LPI.

  • Change of retinal nerve layer thickness

    Baseline and 3 months after LPI.

  • +4 more secondary outcomes

Study Arms (3)

corneoscleral limbus group

EXPERIMENTAL

Laser spot locates on the corneoscleral limbus.

Procedure: Corneoscleral limbus group

One spot group

EXPERIMENTAL

Laser spot locates on one spot away from the corneoscleral limbus

Procedure: one spot group

Two spots group

EXPERIMENTAL

Laser spot locates on two spots away from the corneoscleral limbus

Procedure: two spots group

Interventions

Corneoscleral limbus groupPROCEDURE

Laser spot locates on the corneoscleral limbus

corneoscleral limbus group
one spot groupPROCEDURE

Laser spot locates on one spot away from the corneoscleral limbus

One spot group
two spots groupPROCEDURE

Laser spot locates on two spots away from the corneoscleral limbus

Two spots group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with primary angle closure suspect (PACS), primary angle closure (PAC) or primary angle closure glaucoma (PACG).
  • PACS is diagnosed in eyes with an occludable angle but no other abnormality.
  • PAC is diagnosed in eyes with an occludable angle, normal optic discs and visual fields and any of the following: raised IOP (\>19 mm Hg), PAS, pigment smearing in the superior angle, or sequelae of acute angle closure (iris whirling or glaucomatous fleck).
  • PACG is diagnosed in eyes with an occludable angle and glaucomatous optic neuropathy. Evidence of glaucomatous optic neuropathy is defined as a cup: disc ratio (CDR) of \>0.7 or \>0.2 CDR asymmetry.
  • An occludable angle is defined as one in which three quarters of the posterior pigmented trabecular meshwork is not visible on viewing with a Goldmann two mirror lens in the primary position of gaze without indentation.

You may not qualify if:

  • Patients with previous ocular surgery, and those with secondary angle closure, such as lens intumescence or subluxation, iris neovascularisation and a history of uveitis.
  • Patients who have systemic contraindications to medical therapy (including renal impairment, sulfur allergy, asthma and heart failure), pre-existing corneal opacities obstructing laser access to more than one quadrant of the peripheral iris and single-eyed patients are also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Lai J, Choy BN, Shum JW. Management of Primary Angle-Closure Glaucoma. Asia Pac J Ophthalmol (Phila). 2016 Jan-Feb;5(1):59-62. doi: 10.1097/APO.0000000000000180.

    PMID: 26886121BACKGROUND

  • Narayanaswamy A, Baskaran M, Perera SA, Nongpiur ME, Htoon HM, Tun TA, Wong TT, Goh D, Su DH, Chew PT, Ho CL, Aung T. Argon Laser Peripheral Iridoplasty for Primary Angle-Closure Glaucoma: A Randomized Controlled Trial. Ophthalmology. 2016 Mar;123(3):514-21. doi: 10.1016/j.ophtha.2015.11.002. Epub 2015 Dec 23.

    PMID: 26707418BACKGROUND

  • Marchini G, Chemello F, Berzaghi D, Zampieri A. New findings in the diagnosis and treatment of primary angle-closure glaucoma. Prog Brain Res. 2015;221:191-212. doi: 10.1016/bs.pbr.2015.05.001. Epub 2015 Jun 30.

    PMID: 26518079BACKGROUND

  • Sng CC, Aquino MC, Liao J, Zheng C, Ang M, Chew PT. Anterior segment morphology after acute primary angle closure treatment: a randomised study comparing iridoplasty and medical therapy. Br J Ophthalmol. 2016 Apr;100(4):542-8. doi: 10.1136/bjophthalmol-2015-307087. Epub 2015 Aug 20.

    PMID: 26294102BACKGROUND

  • Wright C, Tawfik MA, Waisbourd M, Katz LJ. Primary angle-closure glaucoma: an update. Acta Ophthalmol. 2016 May;94(3):217-25. doi: 10.1111/aos.12784. Epub 2015 Jun 27.

    PMID: 26119516BACKGROUND

  • 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

  • Lee JR, Choi JY, Kim YD, Choi J. Laser peripheral iridotomy with iridoplasty in primary angle closure suspect: anterior chamber analysis by pentacam. Korean J Ophthalmol. 2011 Aug;25(4):252-6. doi: 10.3341/kjo.2011.25.4.252. Epub 2011 Jul 22.

    PMID: 21860572BACKGROUND

  • Mochizuki H, Takenaka J, Sugimoto Y, Takamatsu M, Kiuchi Y. Comparison of the prevalence of plateau iris configurations between angle-closure glaucoma and open-angle glaucoma using ultrasound biomicroscopy. J Glaucoma. 2011 Jun-Jul;20(5):315-8. doi: 10.1097/IJG.0b013e3181e3d2da.

    PMID: 20577108BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Maosong Xie, doctor

    Department of ophthalmology, First Affilited Hospital of Fujian Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 17, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

September 13, 2016

Record last verified: 2016-09