Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000148
Status:
UNKNOWN
Last Update Posted:
2006-06-05
First Post:
1999-09-23
Brief Title:
Advanced Glaucoma Intervention Study AGIS
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2003-10
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 assess the long-range outcomes of sequences of interventions involving trabeculectomy and argon laser trabeculoplasty in eyes that have failed initial medical treatment for glaucoma
Detailed Description:
In advanced glaucoma medication alone no longer reduces intraocular pressure adequately and the eye has field defects Before 1980 some type of filtering surgery such as trabeculectomy was the usual method of intervention Since then laser trabeculoplasty has become a popular alternative Sometimes the first intervention chosen succeeds in controlling pressure for many years at other times the success lasts only a few weeks or months Because success is limited some patients over time need to undergo a sequence of surgical interventions Little is known about which sequence gives the best long-range outcome
The Advanced Glaucoma Intervention Study AGIS is designed to provide a comprehensive assessment of the long-range outcomes of medical and surgical management in advanced glaucoma The study uses visual function status to compare two intervention sequences in managing the disease
Eligible eyes are randomly assigned to one of two intervention sequences 1 trabeculectomy followed by argon laser trabeculoplasty ALT should trabeculectomy fail followed by a second trabeculectomy should ALT fail or 2 ALT followed by trabeculectomy should ALT fail followed by another trabeculectomy should the first trabeculectomy fail Antifibrotic agents may be used as an adjunct to trabeculectomy but only in eyes with a previous history of invasive surgery Eyes that fail the entire assigned sequence of interventions are managed at the discretion of the AGIS physician in collaboration with the patient
Interventions are supplemented with medical treatment as needed A total of 789 eyes with advanced glaucoma have been enrolled All patients are being followed under a standardized protocol for a minimum of 5 years to determine degree of visual function loss failure rates of interventions rates of complications and need for supplemental therapy
After the initial intervention followup examinations are scheduled at 1 week 4 weeks 3 months 6 months and every 6 months thereafter After second and third interventions followup examinations are scheduled at 1 and 4 weeks Additional visits are scheduled as necessary for the management of the disease
The primary outcome variable in AGIS is average percent of eyes with decrease of vision where decrease of vision is a substantial decline of either visual field or visual acuity attributable to the effect of glaucoma Secondary outcome variables include sustained decrease of vision failure of interventions number of prescribed glaucoma medications and level of intraocular pressure An ancillary study is assessing filtering bleb encapsulation
The Advanced Glaucoma Intervention Study AGIS is designed to provide a comprehensive assessment of the long-range outcomes of medical and surgical management in advanced glaucoma The study uses visual function status to compare two intervention sequences in managing the disease
Eligible eyes are randomly assigned to one of two intervention sequences 1 trabeculectomy followed by argon laser trabeculoplasty ALT should trabeculectomy fail followed by a second trabeculectomy should ALT fail or 2 ALT followed by trabeculectomy should ALT fail followed by another trabeculectomy should the first trabeculectomy fail Antifibrotic agents may be used as an adjunct to trabeculectomy but only in eyes with a previous history of invasive surgery Eyes that fail the entire assigned sequence of interventions are managed at the discretion of the AGIS physician in collaboration with the patient
Interventions are supplemented with medical treatment as needed A total of 789 eyes with advanced glaucoma have been enrolled All patients are being followed under a standardized protocol for a minimum of 5 years to determine degree of visual function loss failure rates of interventions rates of complications and need for supplemental therapy
After the initial intervention followup examinations are scheduled at 1 week 4 weeks 3 months 6 months and every 6 months thereafter After second and third interventions followup examinations are scheduled at 1 and 4 weeks Additional visits are scheduled as necessary for the management of the disease
The primary outcome variable in AGIS is average percent of eyes with decrease of vision where decrease of vision is a substantial decline of either visual field or visual acuity attributable to the effect of glaucoma Secondary outcome variables include sustained decrease of vision failure of interventions number of prescribed glaucoma medications and level of intraocular pressure An ancillary study is assessing filtering bleb encapsulation
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