Prospective Evaluation of the Efficacy of Pascal Laser Iridotomy and Pascal Laser Peripheral Iridoplasty: A Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ophthalmology, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01020071
First received: November 22, 2009
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

Objective: The main objective of this study is to evaluate the efficacy of Pascal Laser Iridotomy and Pascal Laser Peripheral Iridoplasty in lowering intraocular pressure and opening up the angles in patients with narrow angles, primary angle closure and primary angle closure glaucoma.

The specific objectives are to evaluate the pain and inflammation associated with the procedure and its possible adverse effects on the lens and corneal endothelium.

Study Design: Prospective, interventional case series Study Population: Healthy males and females with appositional angle closure aged 21 y/o and above Methods: Potential participants are evaluated by a glaucoma specialist in National University Hospital. If they are identified as having appositional angle closure they are invited to participate in the study and assigned to either iridotomy or iridoplasty depending on the mechanism of angle closure present. Pupil block for Pascal Laser Iridotomy and plateau iris and angle crowding for Pascal Laser Peripheral Iridoplasty. If they agree to participate they will undergo visual acuity, slit lamp examination, intraocular pressure determination by Goldmann Applanation Tonometry, gonioscopy, optic nerve head evaluation by indirect ophthalmoscopy and lens evaluation by LOCS III opacity grading system. Humphrey visual field examination using 24-2 SITA standard algorithm and stereodisc photos will be obtained if not done within the past 12 months. Anterior segment OCT and laser flare meter will also be performed prior to the procedure. Enrolled patients will be divided into 2 groups. The first group will be assigned to Pascal Laser Iridotomy. The primary mechanism of angle closure in this group is pupillary block. The second group will be assigned to Pascal Laser Peripheral Iridoplasty. This group has non-pupil bock mechanisms which include plateau iris or angle crowding. After the laser procedure, follow-up examinations will be done 1 hr post laser, 1 week, 1 month, 3 months and 6 months.

Outcome Measures: The primary outcome measures are the intraocular pressure difference pre and post laser and the opening of angles. Secondary outcome measures are pain and inflammation associated with laser procedure, lens and corneal endothelial changes.


Condition Intervention
Glaucoma
Procedure: pattern scanning laser iridotomy and iridoplasty

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Evaluation of the Efficacy of Pascal Laser Iridotomy and Pascal Laser Peripheral Iridoplasty: A Pilot Study

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • The primary outcome measures are the intraocular pressure difference pre and post laser and the opening of angles. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary outcome measures are pain and inflammation associated with laser procedure, lens and corneal endothelial changes. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: April 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
laser treatment
laser peripheral iridotomy and laser peripheral iridoplasty
Procedure: pattern scanning laser iridotomy and iridoplasty
peripheral laser iridotomy and iridoplasty using pattern scanning laser technique
Other Name: PASCAL

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • healthy males and females having 2 sighted eyes aging 21 y/o and above
  • primary angle closure with pupil block component
  • plateau iris syndrome or plateau iris configuration
  • occludable angles 180 deg and above
  • have uncontrolled IOP (>21 mmHg)
  • able to follow up
  • able to give informed consent

Exclusion Criteria:

  • advanced visual field defect affecting 10 degrees of fixation
  • previous ocular surgeries
  • advanced corneal edema or opacification
  • flat anterior chamber
  • synechially closed angles
  • coexisting ocular pathology except cataract
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020071

Locations
Singapore
National University Hospital
Kent Ridge, Singapore, 111974
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Paul TK Chew, FRCOphth National University Hospital, Singapore
  More Information

No publications provided

Responsible Party: Ophthalmology, Associate Professor Paul Chew, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01020071     History of Changes
Other Study ID Numbers: DSRB A/09/93
Study First Received: November 22, 2009
Last Updated: April 24, 2014
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
iridotomy
iridoplasty
angle closure glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 19, 2014