Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001395
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Long Term Follow-Up of Diabetic Retinopathy
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Long Term Follow-Up of Diabetic Retinopathy
Status:
COMPLETED
Status Verified Date:
1999-03
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:
None
Brief Summary:
The efficacy of laser photocoagulation treatment for diabetic retinopathy has been demonstrated by several National Eye Institute NEI sponsored clinical trials The Diabetic Retinopathy Study DRS demonstrated that scatter photocoagulation reduces the risk of blindness from diabetic retinopathy The Early Treatment Diabetic Retinopathy Study ETDRS extended these findings by providing information on when to initiate scatter photocoagulation and by demonstrating that focal treatment was effective in treating macula edema The Krypton Argon Regression Neovascularization Study KARNS showed that scatter photocoagulation with krypton red laser was just as safe and effective as the argon blue-green laser in the treatment of proliferative diabetic retinopathy
Unfortunately there is little data on the long term effects of photocoagulation on visual function The first objective of this study is to assess the long term effects of photocoagulation for diabetic retinopathy A second objective is to provide additional information on the risk of progression of cataracts in persons with diabetes All patients previously treated with laser photocoagulation focal andor scatter are eligible to participate in this long term study The first priority will be given to patients who participated in the ETDRS and KARNS because of the wealth of information available regarding the details of their treatment and course after treatment Study evaluations will include a standard ophthalmic examination fluorescein angiography lens and fundus photography
Unfortunately there is little data on the long term effects of photocoagulation on visual function The first objective of this study is to assess the long term effects of photocoagulation for diabetic retinopathy A second objective is to provide additional information on the risk of progression of cataracts in persons with diabetes All patients previously treated with laser photocoagulation focal andor scatter are eligible to participate in this long term study The first priority will be given to patients who participated in the ETDRS and KARNS because of the wealth of information available regarding the details of their treatment and course after treatment Study evaluations will include a standard ophthalmic examination fluorescein angiography lens and fundus photography
Detailed Description:
The efficacy of laser photocoagulation treatment for diabetic retinopathy has been demonstrated by several National Eye Institute NEI sponsored clinical trials The Diabetic Retinopathy Study DRS demonstrated that scatter photocoagulation reduces the risk of blindness from diabetic retinopathy The Early Treatment Diabetic Retinopathy Study ETDRS extended these findings by providing information on when to initiate scatter photocoagulation and by demonstrating that focal treatment was effective in treating macula edema The Krypton Argon Regression Neovascularization Study KARNS showed that scatter photocoagulation with krypton red laser was just as safe and effective as the argon blue-green laser in the treatment of proliferative diabetic retinopathy
Unfortunately there is little data on the long term effects of photocoagulation on visual function The first objective of this study is to assess the long term effects of photocoagulation for diabetic retinopathy A second objective is to provide additional information on the risk of progression of cataracts in persons with diabetes All patients previously treated with laser photocoagulation focal andor scatter are eligible to participate in this long term study The first priority will be given to patients who participated in the ETDRS and KARNS because of the wealth of information available regarding the details of their treatment and course after treatment Study evaluations will include a standard ophthalmic examination fluorescein angiography lens and fundus photography
Unfortunately there is little data on the long term effects of photocoagulation on visual function The first objective of this study is to assess the long term effects of photocoagulation for diabetic retinopathy A second objective is to provide additional information on the risk of progression of cataracts in persons with diabetes All patients previously treated with laser photocoagulation focal andor scatter are eligible to participate in this long term study The first priority will be given to patients who participated in the ETDRS and KARNS because of the wealth of information available regarding the details of their treatment and course after treatment Study evaluations will include a standard ophthalmic examination fluorescein angiography lens and fundus photography
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 |
|---|---|---|---|
| 94-EI-0106 | None | None | None |