Open-Angle GlaucomaPhase 3NCT00000149
Collaborative Initial Glaucoma Treatment Study (CIGTS)
A Phase 3 study testing Beta Blocker, Trabeculectomy and Argon Laser Trabeculoplasty in people with Open-Angle Glaucoma, run by National Eye Institute (NEI).
Trial summary
To compare the long-term effect of treating newly diagnosed open-angle glaucoma with standard medical treatment versus filtration surgery. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Open-Angle Glaucoma
- What is being tested?
- Beta Blocker, Trabeculectomy and Argon Laser Trabeculoplasty
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Oct 1993to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
About this study
To compare the long-term effect of treating newly diagnosed open-angle glaucoma with standard medical treatment versus filtration surgery.
Read the detailed description
Recent studies have challenged the conventional wisdom of treating all newly diagnosed open-angle glaucoma (OAG) with eyedrops; rather, these studies suggest that more effective control of glaucomatous damage can be obtained by immediate filtration surgery. In addition, increased attention to the impact of therapy on health-related quality of life has added another consideration in deciding upon appropriate treatment of such patients.
The Collaborative Initial Glaucoma Treatment Study (CIGTS), a randomized, controlled clinical trial, is being conducted to determine whether patients with newly diagnosed OAG are best managed by the conventional approach of topical pharmacologic agents or by immediate filtration surgery. Eligible patients were randomized to receive either a stepped medication treatment regimen or filtration surgery to control their OAG. Sample size requirements indicated that 300 patients were needed for each treatment approach; a total of 607 patients were ultimately recruited for the CIGTS.
Patients randomized to the medication treatment arm are receiving a stepped regimen of topical medications, beginning with a single agent (typically a beta blocker), with additional medications added upon documented lack of intraocular pressure control or evidence of progressive visual field loss. If medications fail to control the patient's OAG, a series of treatment steps begin with argon laser trabeculoplasty and conclude with trabeculectomy.
In the surgical treatment arm, patients underwent immediate trabeculectomy and, with documented failure, proceed to argon laser trabeculectomy, then conclude with medications. Patients, rather than eyes, are randomized to the two treatment arms; if both eyes are eligible for treatment, the treatment course for both eyes is the same and was determined in the randomization.
Following randomization, participating community ophthalmologists affiliated with the study have been allowed to manage the medical and surgical care of study patients. However, all patients are seen at the Clinical Centers for standardized followup examinations at 3 and 6 months after treatment and every 6 months thereafter; in addition, patients randomized to the surgical arm will receive, at a minimum, postsurgical followup at 1 day, 1 week, and 1 month. At the Clinical Center visits, examination of the eye(s) includes evaluation of visual acuity, visual field, and intraocular pressure. The results of these tests determine whether treatment should be changed. In addition, before and at regular intervals after treatment, patients are being interviewed by telephone to assess their health-related quality of life. A questionnaire that includes the Sickness Impact Profile, Visual Activities Questionnaire, and other components is being used.
- Conditions
- Open-Angle Glaucoma
- Being tested
- Beta Blocker, Trabeculectomy, Argon Laser Trabeculoplasty
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta BlockerDrug
TrabeculectomyProcedure or surgery
Argon Laser TrabeculoplastyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 1999 (estimated)
- Study startOct 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Open-Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000149
- Sponsor's protocol ID
- NEI-50
- Status last verified
- Jun 2002
- First submitted
- 23 Sep 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
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
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
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.
PubMed 11442181Lichter 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.
PubMed 11713061Janz 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.
PubMed 11713062Janz 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.
PubMed 11320018Musch 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.
PubMed 10201583Rolim-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.
PubMed 35943114Musch 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.
PubMed 28408039Gillespie 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.
PubMed 24906863Musch 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.
PubMed 24727262Parrish 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.
PubMed 19152871
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Initial Glaucoma Treatment Study (CIGTS)
- ClinicalTrials.gov ID
- NCT00000149
- Acronym / sponsor ID
- NEI-50
- Conditions
- Open-Angle Glaucoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- Oct 1993
- First posted
- 24 Sep 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the long-term effect of treating newly diagnosed open-angle glaucoma with standard medical treatment versus filtration surgery.
Detailed description
Recent studies have challenged the conventional wisdom of treating all newly diagnosed open-angle glaucoma (OAG) with eyedrops; rather, these studies suggest that more effective control of glaucomatous damage can be obtained by immediate filtration surgery. In addition, increased attention to the impact of therapy on health-related quality of life has added another consideration in deciding upon appropriate treatment of such patients.
The Collaborative Initial Glaucoma Treatment Study (CIGTS), a randomized, controlled clinical trial, is being conducted to determine whether patients with newly diagnosed OAG are best managed by the conventional approach of topical pharmacologic agents or by immediate filtration surgery. Eligible patients were randomized to receive either a stepped medication treatment regimen or filtration surgery to control their OAG. Sample size requirements indicated that 300 patients were needed for each treatment approach; a total of 607 patients were ultimately recruited for the CIGTS.
Patients randomized to the medication treatment arm are receiving a stepped regimen of topical medications, beginning with a single agent (typically a beta blocker), with additional medications added upon documented lack of intraocular pressure control or evidence of progressive visual field loss. If medications fail to control the patient's OAG, a series of treatment steps begin with argon laser trabeculoplasty and conclude with trabeculectomy.
In the surgical treatment arm, patients underwent immediate trabeculectomy and, with documented failure, proceed to argon laser trabeculectomy, then conclude with medications. Patients, rather than eyes, are randomized to the two treatment arms; if both eyes are eligible for treatment, the treatment course for both eyes is the same and was determined in the randomization.
Following randomization, participating community ophthalmologists affiliated with the study have been allowed to manage the medical and surgical care of study patients. However, all patients are seen at the Clinical Centers for standardized followup examinations at 3 and 6 months after treatment and every 6 months thereafter; in addition, patients randomized to the surgical arm will receive, at a minimum, postsurgical followup at 1 day, 1 week, and 1 month. At the Clinical Center visits, examination of the eye(s) includes evaluation of visual acuity, visual field, and intraocular pressure. The results of these tests determine whether treatment should be changed. In addition, before and at regular intervals after treatment, patients are being interviewed by telephone to assess their health-related quality of life. A questionnaire that includes the Sickness Impact Profile, Visual Activities Questionnaire, and other components is being used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta Blocker | Drug | – |
| Trabeculectomy | Procedure or surgery | – |
| Argon Laser Trabeculoplasty | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- BackgroundJanz 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
- BackgroundLichter 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: PubMed 11442181Mills 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.
- Background: PubMed 11713061Lichter 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.
- Background: PubMed 11713062Janz 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.
- Background: PubMed 11320018Janz 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.
- Background: PubMed 10201583Musch 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.
- Derived from this study: PubMed 35943114Rolim-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.
- Derived from this study: PubMed 28408039Musch 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.
- Derived from this study: PubMed 24906863Gillespie 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.
- Derived from this study: PubMed 24727262Musch 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.
- Derived from this study: PubMed 19152871Parrish 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Beta Blocker, Trabeculectomy and Argon Laser Trabeculoplasty in people with Open-Angle Glaucoma, run by National Eye Institute (NEI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000149, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.