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

NCT01020071 | Completed

• 1 other identifier: DSRB A/09/93
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glaucoma

Keywords

iridotomy; iridoplasty; angle closure glaucoma

Outcome Measures

Primary Outcomes (1)

• The primary outcome measures are the intraocular pressure difference pre and post laser and the opening of angles.

  6 months

Secondary Outcomes (1)

• Secondary outcome measures are pain and inflammation associated with laser procedure, lens and corneal endothelial changes.

  6 months

Study Arms (1)

laser treatment

OTHER

laser peripheral iridotomy and laser peripheral iridoplasty

Procedure: pattern scanning laser iridotomy and iridoplasty

Interventions

pattern scanning laser iridotomy and iridoplasty PROCEDURE

peripheral laser iridotomy and iridoplasty using pattern scanning laser technique

Also known as: PASCAL

laser treatment

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Kent Ridge, Singapore, 111974, Singapore

Location

MeSH Terms

Conditions

Glaucoma; Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Paul TK Chew, FRCOphth

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Paul Chew

Study Record Dates

• First Submitted: November 22, 2009
• First Posted: November 25, 2009
• Study Start: April 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

SG (1)