SALT: Steroids After Laser Trabeculoplasty for Glaucoma

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00981435
• Collaborator: Bascom Palmer Eye Institute (Other), University of Pittsburgh Medical Center (Other)
• Enrollment: 97
• Locations: 2
• Arms: 3
• Duration (Months): 72
• Patients Per Site: 48.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether the choice of post-operative eye drop administered after selective laser trabeculoplasty (SLT) for glaucoma affects the efficacy in lowering intraocular pressure (IOP).

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: Prednisolone 1%; Drug: Ketorolac; Drug: Artificial Tears	Phase 4

Detailed Description

SLT is used to lower intraocular pressure in glaucoma, but it is not know whether the choice of eyedrops administered in the post-operative period affects SLT efficacy. Practitioners commonly use steroid drops, non-steroidal anti-inflammatory drops, or no drops at all. This is a randomized, single-center, prospective, masked clinical trial to determine whether the choice of eyedrop affects efficacy of SLT in glaucoma patients.

Study Design

• Study Type: Interventional
• Actual Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Steroids And Laser Trabeculoplasty (SALT) Trial: Effect of Anti-Inflammatory Treatment on the Efficacy of SLT
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Artificial Tears Topical artificial tears dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.	Drug: Artificial Tears; Artificial saline tears to lasered eye 4 times/day for 4.5 days; Other Names: saline tears
Experimental: Non-steroidal anti-inflammatory Topical ketorolac 0.5% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.	Drug: Ketorolac; Ketorolac 0.5% to lasered eye 4 times/day for 4.5 days; Other Names: Voltaren
Experimental: Steroid Topical prednisolone 1% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.	Drug: Prednisolone 1%; Prednisolone 1% to lasered eye 4 times/day for 4.5 days; Other Names: Pred forte

Outcome Measures

Primary Outcome Measures

1. Intraocular Pressure (IOP) Change [Baseline to Week 12]

   IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry.

Secondary Outcome Measures

1. Intraocular Inflammation [Up to week 12]

   The count of patients with inflammation defined as anterior chamber cells was measured in each study arm.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• clinical diagnosis of glaucoma

• clinician has determined that SLT laser is indicated

• IOP currently >18 and was ever >21 in the past (e.g. prior to treatment)

Exclusion Criteria:

• prior history of uveitis

• prior glaucoma surgery including glaucoma laser surgery

• pregnant or 3 months post-partum

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bascom Palmer Eye Institute	Miami	Florida	United States	33136
2	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• Stanford University
• Bascom Palmer Eye Institute
• University of Pittsburgh Medical Center

Investigators

• Principal Investigator: Jeffrey L Goldberg, MD, PhD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeffrey L Goldberg, Professor of Ophthalmology, Stanford University
• ClinicalTrials.gov Identifier: NCT00981435
• Other Study ID Numbers: 20081142
• First Posted: Sep 22, 2009
• Last Update Posted: Aug 7, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Jeffrey L Goldberg, Professor of Ophthalmology, Stanford University: Glaucoma; Trabeculoplasty; Selective laser trabeculoplasty; Intraocular pressure
• Additional relevant MeSH terms: Glaucoma; Prednisolone; Prednisolone acetate; Ketorolac; Lubricant Eye Drops

Study Results

Participant Flow

Arm/Group Title	Artificial Tears	Non-steroidal Anti-inflammatory	Steroid
Arm/Group Description	Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days	Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days	Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
Period Title: Overall Study
STARTED	31	29	37
COMPLETED	31	29	37
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Artificial Tears	Non-steroidal Anti-inflammatory	Steroid	Total
Arm/Group Description	Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days	Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days	Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days	Total of all reporting groups
Overall Participants	31	29	37	97
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (15)	60 (11)	67 (14)	65 (14)
Sex: Female, Male (Count of Participants)
Female	19 61.3%	14 48.3%	23 62.2%	56 57.7%
Male	12 38.7%	15 51.7%	14 37.8%	41 42.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 32.3%	5 17.2%	11 29.7%	26 26.8%
Not Hispanic or Latino	20 64.5%	23 79.3%	24 64.9%	67 69.1%
Unknown or Not Reported	1 3.2%	1 3.4%	2 5.4%	4 4.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	6 19.4%	7 24.1%	8 21.6%	21 21.6%
White	25 80.6%	21 72.4%	29 78.4%	75 77.3%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 3.4%	0 0%	1 1%

Outcome Measures

1. Primary Outcome

Title	Intraocular Pressure (IOP) Change
Description	IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Patient data was incomplete due to inadequate measurement or follow up as follows: Artificial tears (31 enrolled, 27 available at 6 weeks, 25 at 12 weeks); Non-steroidal anti-inflammatory (28 enrolled, 27 available at 6 and 12 weeks); Steroid (37 enrolled, 33 available at 6 weeks, 29 at 12 weeks).

Arm/Group Title	Artificial Tears	Non-steroidal Anti-inflammatory	Steroid
Arm/Group Description	Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days	Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days	Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
Measure Participants	25	27	29
Mean (Standard Deviation) [mmHg]	-3.0 (4.3)	-6.2 (3.1)	-5.2 (2.7)

2. Secondary Outcome

Title	Intraocular Inflammation
Description	The count of patients with inflammation defined as anterior chamber cells was measured in each study arm.
Time Frame	Up to week 12

Outcome Measure Data

Analysis Population Description

Patient data was incomplete due to inadequate measurement or follow up as follows: Artificial tears (31 enrolled, 31 available for data acquisition); Non-steroidal anti-inflammatory (29 enrolled, 26 available for data acquisition); Steroid (37 enrolled, 35 available for data acquisition).

Arm/Group Title	Artificial Tears	Non-steroidal Anti-inflammatory	Steroid
Arm/Group Description	Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days	Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days	Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
Measure Participants	31	26	35
Count of Participants [Participants]	0 0%	0 0%	0 0%

Adverse Events

Time Frame	Up to 12 weeks
Adverse Event Reporting Description	Adverse events and serious adverse events were pre-defined and evaluated by examining physician at every study visit.
Arm/Group Title	Artificial Tears		Non-steroidal Anti-inflammatory		Steroid
Arm/Group Description	Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days		Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days		Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
All Cause Mortality
	Artificial Tears		Non-steroidal Anti-inflammatory		Steroid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Artificial Tears		Non-steroidal Anti-inflammatory		Steroid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/29 (0%)		0/37 (0%)
Other (Not Including Serious) Adverse Events
	Artificial Tears		Non-steroidal Anti-inflammatory		Steroid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/29 (0%)		0/37 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.