Steroids After Laser Trabeculoplasty for Glaucoma

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StatusasBaigta

Rėmėjai

Stanford University

Bendradarbiai

Bascom Palmer Eye Institute

University of Pittsburgh Medical Center

KLINIKINIS TYRIMAS: NCT00981435

BioSeek: nct00981435

Raktažodžiai

Santrauka

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).

apibūdinimas

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.

Datos

Paskutinį kartą patikrinta:	06/30/2019
Pirmasis pateikimas:	09/20/2009
Numatytas registravimas pateiktas:	09/20/2009
Pirmas paskelbtas:	09/21/2009
Paskutinis atnaujinimas pateiktas:	07/22/2019
Paskutinis atnaujinimas paskelbtas:	08/06/2019
Pirmųjų rezultatų pateikimo data:	12/27/2016
Pirmojo QC rezultatų pateikimo data:	02/27/2017
Pirmųjų paskelbtų rezultatų data:	04/13/2017
Faktinė studijų pradžios data:	08/31/2009
Numatoma pirminio užbaigimo data:	08/31/2015
Numatoma studijų užbaigimo data:	08/31/2015

Būklė ar liga

Glaucoma

Intervencija / gydymas

Drug: Steroid

Drug: Non-steroidal anti-inflammatory

Drug: Artificial Tears

Fazė

Fazė 4

Rankų grupės

Ranka	Intervencija / gydymas
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
Experimental: Non-steroidal anti-inflammatory Topical ketorolac 0.5% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.	Drug: Non-steroidal anti-inflammatory Ketorolac 0.5% to lasered eye 4 times/day for 4.5 days
Experimental: Steroid Topical prednisolone 1% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.	Drug: Steroid Prednisolone 1% to lasered eye 4 times/day for 4.5 days

Tinkamumo kriterijai

Amžius, tinkami studijuoti	18 Years Į 18 Years
Tinkamos studijoms lytys	All
Priima sveikus savanorius	Taip
Kriterijai	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

Rezultatas

Pirminės rezultatų priemonės

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.

Antrinės rezultatų priemonės

1. Intraocular Inflammation [Up to week 12]

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