The Role of Steroids Following Selective Laser Trabeculoplasty

• Sponsor: West Virginia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00406042
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Duration (Months): 9
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

To evaluate whether or not using topical steroids after selective laser trabeculoplasty affects intraocular pressure outcomes.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: prednisolone acetate 1%	N/A

Detailed Description

Subjects undergoing bilateral SLT will be randomly assigned to use prednisolone acetate 1% in one eye four times daily with no treatment in the fellow eye, for one week following SLT. Examinations will occur at baseline, and one week, one month and three months after SLT. IOP and anterior chamber inflammation will be noted at each visit.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: The Role of Topical Prednisolone Acetate Following Selective Laser Trabeculoplasty
• Study Start Date: Sep 1, 2005
• Actual Study Completion Date: Jun 1, 2006

Outcome Measures

Primary Outcome Measures

1. Intraocular pressure reduction []

Secondary Outcome Measures

1. Anterior chamber inflammation []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• glaucoma or ocular hypertension

• need for bilateral SLT

Exclusion Criteria:

• eye disease precluding accurate IOP measurement

• contraindication to topical prednisolone acetate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Virginia University Eye Institute	Morgantown	West Virginia	United States	26505

Sponsors and Collaborators

• West Virginia University

Investigators

• Principal Investigator: Tony Realini, MD, West Virginia University Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00406042
• Other Study ID Numbers: 16678
• First Posted: Dec 4, 2006
• Last Update Posted: Mar 29, 2007
• Last Verified: Mar 1, 2007

• Keywords provided by , ,: glaucoma; trabeculoplasty; steroids
• Additional relevant MeSH terms: Glaucoma; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

No Results Posted as of Mar 29, 2007