Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000149
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-09-23
Brief Title:
Collaborative Initial Glaucoma Treatment Study CIGTS
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2002-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 patients 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 eyes 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
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 patients 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 eyes 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None