Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000158
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-09-23
Brief Title:
Macular Photocoagulation Study MPS
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 evaluate laser treatment of choroidal neovascularization CNV through randomized controlled clinical trials The Macular Photocoagulation Study MPS consisted of three sets of randomized controlled clinical trials Change in best-corrected visual acuity from baseline was the primary outcome for all MPS trials Other measures of vision are evaluated in each set of trials The purpose of each is described below
Argon Study To determine whether argon blue-green laser photocoagulation of leaking abnormal blood vessels in choroidal neovascular membranes outside the fovea 200 to 2500 microns from the center of the foveal avascular zone FAZ is of benefit in preventing or delaying loss of central vision in patients with age-related senile macular degeneration AMD presumed ocular histoplasmosis POH and idiopathic neovascular membranes INVM A separate trial was conducted for each of the three underlying conditions
Krypton Study To determine whether krypton red laser photocoagulation of choroidal neovascular lesions with the posterior border 1 to 199 microns from the center of the FAZ is of benefit in preventing or delaying large losses of visual acuity in patients with AMD POH and INVM A separate trial was conducted for each of the three underlying conditions
Foveal Study To determine whether laser photocoagulation is of benefit in preventing or delaying further visual acuity loss in patients with new never treated or recurrent previously treated with laser photocoagulation choroidal neovascularization under the center of the FAZ Two separate trials one for each type of lesion were carried out
Argon Study To determine whether argon blue-green laser photocoagulation of leaking abnormal blood vessels in choroidal neovascular membranes outside the fovea 200 to 2500 microns from the center of the foveal avascular zone FAZ is of benefit in preventing or delaying loss of central vision in patients with age-related senile macular degeneration AMD presumed ocular histoplasmosis POH and idiopathic neovascular membranes INVM A separate trial was conducted for each of the three underlying conditions
Krypton Study To determine whether krypton red laser photocoagulation of choroidal neovascular lesions with the posterior border 1 to 199 microns from the center of the FAZ is of benefit in preventing or delaying large losses of visual acuity in patients with AMD POH and INVM A separate trial was conducted for each of the three underlying conditions
Foveal Study To determine whether laser photocoagulation is of benefit in preventing or delaying further visual acuity loss in patients with new never treated or recurrent previously treated with laser photocoagulation choroidal neovascularization under the center of the FAZ Two separate trials one for each type of lesion were carried out
Detailed Description:
In each randomized trial conducted by the MPS Group focal laser photocoagulation was compared to observation without treatment Patients were assigned to laser treatment or to observation with equal probability The first set of MPS randomized trials the Argon Study focused on the effectiveness of photocoagulation with argon blue-green laser in eyes with discrete extrafoveal choroidal neovascularization The study investigators who began recruiting patients in 1979 estimated that 550 patients with AMD and 750 with POH would be required Follow-up was to continue for 5 years to determine whether argon laser photocoagulation treatment could prevent or delay visual acuity loss in these patients
After the initiation of the Argon Study a new krypton red laser became available The new wavelength offered theoretical advantages over the argon laser for treating CNV that extended inside the FAZ of the macula The Krypton Study design was analogous to the Argon Study with the investigation of three underlying conditions except that CNV was closer to the FAZ center
The third set of MPS clinical trials the Foveal Study was designed to determine whether laser photocoagulation was effective for delaying or preventing further visual acuity loss in AMD patients who have subfoveal CNV Among patients assigned to laser treatment in the Foveal Study argon laser treatment was compared with krypton red laser treatment of these lesions The investigators originally projected that about 350 patients would be required for each clinical trial of the Foveal Study
After the initiation of the Argon Study a new krypton red laser became available The new wavelength offered theoretical advantages over the argon laser for treating CNV that extended inside the FAZ of the macula The Krypton Study design was analogous to the Argon Study with the investigation of three underlying conditions except that CNV was closer to the FAZ center
The third set of MPS clinical trials the Foveal Study was designed to determine whether laser photocoagulation was effective for delaying or preventing further visual acuity loss in AMD patients who have subfoveal CNV Among patients assigned to laser treatment in the Foveal Study argon laser treatment was compared with krypton red laser treatment of these lesions The investigators originally projected that about 350 patients would be required for each clinical trial of the Foveal Study
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