Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000125
Status:
COMPLETED
Last Update Posted:
2020-06-02
First Post:
1999-09-23
Brief Title:
Ocular Hypertension Treatment Study OHTS
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Ocular Hypertension Treatment Study OHTS
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
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:
OHTS
Brief Summary:
To determine whether medical reduction of intraocular pressure prevents or delays the onset of glaucomatous visual field loss andor optic disc damage in ocular hypertensive participants judged to be at moderate risk for developing open-angle glaucoma
To produce natural history data to assist in identifying patients at most risk for developing open-angle glaucoma and those most likely to benefit from early medical treatment
To quantify risk factors for developing open-angle glaucoma among ocular hypertensive individuals
To produce natural history data to assist in identifying patients at most risk for developing open-angle glaucoma and those most likely to benefit from early medical treatment
To quantify risk factors for developing open-angle glaucoma among ocular hypertensive individuals
Detailed Description:
OHTS Phase 3 will re-examine study participants 20 plus years after enrollment to document clinical status and the incidence and severity of self-reported functional limitations The 279 participants who developed POAG in OHTS Phase 1 or 2 will have more than 10 years of post-POAG follow-up by Phase 3 The timing of re-examination at 20 years is meaningful because 20 years approaches the median life expectancy of OHT patients in their 60s and 70s and half the median life expectancy of patients in their 40s and 50s For the first time patients with ocular hypertension and clinicians will have high quality data about the long-term risk of developing POAG and functional limitations associated with the disease These data will facilitate patient-centered care so that patients and clinicians can decide on the appropriate frequency of tests and examinations and the potential benefit of preventative treatment
Glaucoma is one of the leading causes of blindness in the United States and other industrialized countries It is estimated that 2 million people in the United States have glaucoma and that 80000 of these individuals are legally blind from the disease Among African Americans glaucoma is now recognized as the leading cause of blindness
Elevated intraocular pressure IOP a common condition affecting 3 to 6 million people in the United States is thought to be the leading risk factor for development of open-angle glaucoma There is no consensus that medical reduction of intraocular pressure prevents or delays the onset of visual field andor optic nerve damage in ocular hypertensive subjects
Despite the lack of convincing evidence for the efficacy of medical treatment in ocular hypertension approximately 15 million glaucoma suspects in the United States are being treated with costly ocular hypotensive medications that carry the potential for serious and even life-threatening side effects
Clearly there is a need for a well-controlled clinical trial to determine whether medical reduction of IOP can prevent or delay the onset of glaucomatous damage in ocular hypertensive subjects Only then can clinicians and patients make rational choices and health care planners ensure that limited medical resources are being allocated in a safe and cost-effective manner
The Ocular Hypertension Treatment Study OHTS is a long-term randomized controlled multicenter clinical trial Ocular hypertensive subjects judged to be at moderate risk of developing primary open-angle glaucoma are randomly assigned to either close observation only or a stepped medical regimen Medical treatment consists of all commercially available topical ocular hypotensive eye drops
After completion of baseline measures IOP visual fields disc photos and randomization the subjects are followed for a minimum of 5 years with automated threshold central static perimetry Humphrey program 30-2 twice yearly and stereoscopic optic disc photographs once yearly Study end points are reproducible visual field loss andor progressive optic disc damage in either eye of a patient attributed to glaucoma by a Masked Endpoint Committee All visual fields and optic disc photographs are read in a masked fashion in Reading Centers
In the 1991 Baltimore Eye Survey African Americans were shown to have a prevalence of open-angle glaucoma four to five times higher than whites Given this high prevalence of glaucoma in the African American population it is important to recruit and follow an adequate sample of African American subjects in the trial approximately 25 percent of the total patient sample
At the conclusion of this study practitioners should be able to make reasonable estimates of risk for individual ocular hypertensive patients and to determine which ocular hypertensive individuals are most likely to benefit from early prophylactic medical treatment
Glaucoma is one of the leading causes of blindness in the United States and other industrialized countries It is estimated that 2 million people in the United States have glaucoma and that 80000 of these individuals are legally blind from the disease Among African Americans glaucoma is now recognized as the leading cause of blindness
Elevated intraocular pressure IOP a common condition affecting 3 to 6 million people in the United States is thought to be the leading risk factor for development of open-angle glaucoma There is no consensus that medical reduction of intraocular pressure prevents or delays the onset of visual field andor optic nerve damage in ocular hypertensive subjects
Despite the lack of convincing evidence for the efficacy of medical treatment in ocular hypertension approximately 15 million glaucoma suspects in the United States are being treated with costly ocular hypotensive medications that carry the potential for serious and even life-threatening side effects
Clearly there is a need for a well-controlled clinical trial to determine whether medical reduction of IOP can prevent or delay the onset of glaucomatous damage in ocular hypertensive subjects Only then can clinicians and patients make rational choices and health care planners ensure that limited medical resources are being allocated in a safe and cost-effective manner
The Ocular Hypertension Treatment Study OHTS is a long-term randomized controlled multicenter clinical trial Ocular hypertensive subjects judged to be at moderate risk of developing primary open-angle glaucoma are randomly assigned to either close observation only or a stepped medical regimen Medical treatment consists of all commercially available topical ocular hypotensive eye drops
After completion of baseline measures IOP visual fields disc photos and randomization the subjects are followed for a minimum of 5 years with automated threshold central static perimetry Humphrey program 30-2 twice yearly and stereoscopic optic disc photographs once yearly Study end points are reproducible visual field loss andor progressive optic disc damage in either eye of a patient attributed to glaucoma by a Masked Endpoint Committee All visual fields and optic disc photographs are read in a masked fashion in Reading Centers
In the 1991 Baltimore Eye Survey African Americans were shown to have a prevalence of open-angle glaucoma four to five times higher than whites Given this high prevalence of glaucoma in the African American population it is important to recruit and follow an adequate sample of African American subjects in the trial approximately 25 percent of the total patient sample
At the conclusion of this study practitioners should be able to make reasonable estimates of risk for individual ocular hypertensive patients and to determine which ocular hypertensive individuals are most likely to benefit from early prophylactic medical treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U10EY009341-14 | NIH | None | httpsreporternihgovquickSearch5U10EY009341-14 |
| 5U10EY009307-16 | NIH | None | None |