Collaborative Initial Glaucoma Treatment Study (CIGTS)

NCT00000149 | Unknown Phase 3

• 1 other identifier: NEI-50
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the long-term effect of treating newly diagnosed open-angle glaucoma with standard medical treatment versus filtration surgery.

Conditions

Open-Angle Glaucoma

Interventions

Beta Blocker DRUG

Trabeculectomy PROCEDURE

Argon Laser Trabeculoplasty PROCEDURE

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Patients must be at least 25 years old with an intraocular pressure of 20 mm Hg or greater and evidence of optic nerve damage and/or visual field loss in one or both eyes. The ocular findings must exclude causes of glaucoma other than primary open-angle glaucoma, pigmentary glaucoma, or pseudoexfoliation glaucoma.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Related Publications (12)

• Janz N; Wren PA; CIGTS Study Group; Implementing quality of life in a clinical trial, in Anderson DR, Drance SM (eds)., The Collaborative Initial Glaucoma Treatment Study. Encounters in Glaucoma Research 3: How to Ascertain Progression and Outcome, 1996:45-62

  BACKGROUND

• Lichter PR; Mills RP; CIGTS Study Group; Quality of life study - determination of progression, in Anderson DR, Drance SM (eds)., Encounters in Glaucoma Research 3: How to Ascertain Progression and Outcome, Amsterdam, Kugler Publications, 1996:149-163

  BACKGROUND

• Mills RP, Janz NK, Wren PA, Guire KE. Correlation of visual field with quality-of-life measures at diagnosis in the Collaborative Initial Glaucoma Treatment Study (CIGTS). J Glaucoma. 2001 Jun;10(3):192-8. doi: 10.1097/00061198-200106000-00008.

  PMID: 11442181 BACKGROUND

• Lichter PR, Musch DC, Gillespie BW, Guire KE, Janz NK, Wren PA, Mills RP; CIGTS Study Group. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001 Nov;108(11):1943-53. doi: 10.1016/s0161-6420(01)00873-9.

  PMID: 11713061 BACKGROUND

• Janz NK, Wren PA, Lichter PR, Musch DC, Gillespie BW, Guire KE, Mills RP; CIGTS Study Group. The Collaborative Initial Glaucoma Treatment Study: interim quality of life findings after initial medical or surgical treatment of glaucoma. Ophthalmology. 2001 Nov;108(11):1954-65. doi: 10.1016/s0161-6420(01)00874-0.

  PMID: 11713062 BACKGROUND

• Janz NK, Wren PA, Lichter PR, Musch DC, Gillespie BW, Guire KE. Quality of life in newly diagnosed glaucoma patients : The Collaborative Initial Glaucoma Treatment Study. Ophthalmology. 2001 May;108(5):887-97; discussion 898. doi: 10.1016/s0161-6420(00)00624-2.

  PMID: 11320018 BACKGROUND

• Musch DC, Lichter PR, Guire KE, Standardi CL. The Collaborative Initial Glaucoma Treatment Study: study design, methods, and baseline characteristics of enrolled patients. Ophthalmology. 1999 Apr;106(4):653-62. doi: 10.1016/s0161-6420(99)90147-1.

  PMID: 10201583 BACKGROUND

• Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.

  PMID: 35943114 DERIVED

• Musch DC, Niziol LM, Gillespie BW, Lichter PR, Janz NK. Binocular Measures of Visual Acuity and Visual Field versus Binocular Approximations. Ophthalmology. 2017 Jul;124(7):1031-1038. doi: 10.1016/j.ophtha.2017.02.013. Epub 2017 Apr 10.

  PMID: 28408039 DERIVED

• Gillespie BW, Musch DC, Niziol LM, Janz NK. Estimating minimally important differences for two vision-specific quality of life measures. Invest Ophthalmol Vis Sci. 2014 Jun 6;55(7):4206-12. doi: 10.1167/iovs.13-13683.

  PMID: 24906863 DERIVED

• Musch DC, Gillespie BW, Palmberg PF, Spaeth G, Niziol LM, Lichter PR. Visual field improvement in the collaborative initial glaucoma treatment study. Am J Ophthalmol. 2014 Jul;158(1):96-104.e2. doi: 10.1016/j.ajo.2014.04.003. Epub 2014 Apr 12.

  PMID: 24727262 DERIVED

• Parrish RK 2nd, Feuer WJ, Schiffman JC, Lichter PR, Musch DC; CIGTS Optic Disc Study Group. Five-year follow-up optic disc findings of the Collaborative Initial Glaucoma Treatment Study. Am J Ophthalmol. 2009 Apr;147(4):717-724.e1. doi: 10.1016/j.ajo.2008.10.007. Epub 2009 Jan 18.

  PMID: 19152871 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Adrenergic beta-Antagonists; Trabeculectomy

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 23, 1999
• First Posted: September 24, 1999
• Study Start: October 1, 1993
• Last Updated: June 24, 2005

Record last verified: 2002-06