Diabetic Retinopathy
Conditions
Keywords
Type 2 Diabetes Mellitus, Cardiovascular Diseases
Brief summary
Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study is examining the effect of various treatments on cardiovascular disease in people with diabetes. This current study will examine the effects of the ACCORD treatments on the progression of DR in people participating in the ACCORD study.
Detailed description
DR is the most common diabetic eye disease and is the leading cause of blindness in adults in the United States. It is caused by damage to the blood vessels of the retina, which is the light-sensitive outer layer of the eye. Retinal blood vessels are often affected by the high blood sugar levels associated with diabetes. Older people have an increased risk of developing DR; however, DR is likely to occur earlier and be more severe in anyone who has poorly controlled diabetes. Almost everyone who has had diabetes for more than 30 years will eventually show signs of DR. Symptoms of DR include poor night vision, seeing spots in front of the eyes, blurred vision, and blindness. The ACCORD study is a study that is examining the effects of different treatments on cardiovascular disease in people with diabetes. Participants in the ACCORD study will receive one of eight different combinations of treatment, including blood sugar control, blood pressure control, and cholesterol-controlling medication. This study will enroll participants in the ACCORD study and will examine the effects of the study treatments on DR. The results from this study may be used to develop new treatments to help prevent diabetes-related blindness. Study visits will occur at baseline and Year 4. At each study visit, participants will have an eye exam and specialized fundus photographs taken of the back of the eye and retina.
Interventions
Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%
DRUGStandard glycemia control
A strategy of glycemia drugs for HbA1c 7% - 7.9%
DRUGIntensive BP treatment
A strategy of multiple BP agents to reduce SBP less than 120 mm Hg
A strategy of BP drugs for SBP less than 140 mm Hg
DRUGFenofibrate
Blinded fenofibrate
DRUGSimvastatin
Simvastatin 20-40 mg/d
DRUGPlacebo
Placebo
Sponsors
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Participating in the ACCORD study
Exclusion criteria
* Has had laser photocoagulation for DR * Has had vitrectomy surgery for DR
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy | Measured at Year 4 | Diabetic retinopathy status was defined according to the eye with the highest level on the ETDRS Final Severity Scale for Persons, as follows: no diabetic retinopathy, a level of less than 20; mild diabetic retinopathy, a level of 20; moderate nonproliferative diabetic retinopathy (NPDR), a level above 20 but less than 53; severe diabetic retinopathy, a level of 53 but less than 60; and proliferative diabetic retinopathy (PDR), a level of 60 or higher. |
Secondary
| Measure | Time frame |
|---|---|
| Cataract Extraction | Measured at Year 4 |
| Development or Progression of Macular Edema | Measured at Year 4 |
| Loss of Visual Acuity | Measured at Year 4 |
Countries
Canada, United States
Participant flow
Recruitment details
Recruitment for the ACCORD Eye study was restricted to participants recruited as part of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study. The ACCORD Eye study began in October 2003, with 3472 participants enrolled by February 2006.
Pre-assignment details
All participants were enrolled in either the intensive or standard glycemia control arms. In addition to inclusion in the glycemia control part of the trial, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo).
Participants by arm
| Arm | Count |
|---|---|
| Intensive Glycemia Control A strategy of intensive glycemia treatment to HbA1c less than 6% | 1,429 |
| Standard Glycemia Control A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9% | 1,427 |
| Intensive BP Control A strategy of BP treatment for SBP less than 120 mm Hg | 647 |
| Standard BP Control A strategy of BP treatment for SBP less than 140 mm Hg | 616 |
| Fibrate Blinded fenofibrate + simvastatin 20-40 mg/d | 806 |
| Fibrate Placebo Blinded placebo + simvastatin 20-40 mg/d | 787 |
| Total | 5,712 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | did not complete year 4 follow-up | 75 | 80 | 74 | 62 | 64 | 89 | 87 | 85 |
Baseline characteristics
| Characteristic | Fibrate | Standard BP Control | Standard Glycemia Control | Intensive Glycemia Control | Fibrate Placebo | Intensive BP Control | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 61.9 years STANDARD_DEVIATION 6.2 | 61.5 years STANDARD_DEVIATION 6.6 | 61.5 years STANDARD_DEVIATION 6.3 | 61.6 years STANDARD_DEVIATION 6.4 | 61.5 years STANDARD_DEVIATION 6.5 | 61.3 years STANDARD_DEVIATION 6.1 | 61.6 years STANDARD_DEVIATION 6.3 |
| BMI Blood Pressure and Lipid Studies | 32.3 kg/m^2 STANDARD_DEVIATION 5.5 | 32.2 kg/m^2 STANDARD_DEVIATION 5.3 | — | — | 32.6 kg/m^2 STANDARD_DEVIATION 5.4 | 32.7 kg/m^2 STANDARD_DEVIATION 5.7 | 32.4 kg/m^2 STANDARD_DEVIATION 5.5 |
| BMI Glycemic Control Study | — | — | 32.5 kg/m^2 STANDARD_DEVIATION 5.4 | 32.4 kg/m^2 STANDARD_DEVIATION 5.5 | — | — | 32.4 kg/m^2 STANDARD_DEVIATION 5.5 |
| Cholesterol (HDL) Blood Pressure and Lipid Studies | 38.6 mg/dl STANDARD_DEVIATION 7.8 | 46.31 mg/dl STANDARD_DEVIATION 13.8 | — | — | 38.5 mg/dl STANDARD_DEVIATION 7.9 | 46.3 mg/dl STANDARD_DEVIATION 12.8 | 41.9 mg/dl STANDARD_DEVIATION 11.3 |
| Cholesterol (HDL) Glycemic Control Study | — | — | 41.9 mg/dl STANDARD_DEVIATION 11.1 | 42.0 mg/dl STANDARD_DEVIATION 11.4 | — | — | 41.9 mg/dl STANDARD_DEVIATION 11.3 |
| Cholesterol (LDL) Blood Pressure and Lipid Studies | 96.5 mg/dl STANDARD_DEVIATION 29.7 | 104.1 mg/dl STANDARD_DEVIATION 33.5 | — | — | 97.0 mg/dl STANDARD_DEVIATION 30.1 | 107.4 mg/dl STANDARD_DEVIATION 37 | 100.7 mg/dl STANDARD_DEVIATION 32.7 |
| Cholesterol (LDL) Glycemic Control Study | — | — | 100.7 mg/dl STANDARD_DEVIATION 32.1 | 100.8 mg/dl STANDARD_DEVIATION 33.4 | — | — | 100.7 mg/dl STANDARD_DEVIATION 32.7 |
| Diastolic Blood Pressure Blood Pressure and Lipid Studies | 73.7 mm Hg STANDARD_DEVIATION 10.5 | 76.8 mm Hg STANDARD_DEVIATION 9.9 | — | — | 73.6 mm Hg STANDARD_DEVIATION 10.5 | 76.3 mm Hg STANDARD_DEVIATION 10.5 | 74.9 mm Hg STANDARD_DEVIATION 10.5 |
| Diastolic Blood Pressure Glycemic Control Study | — | — | 75.0 mm Hg STANDARD_DEVIATION 10.6 | 74.9 mm Hg STANDARD_DEVIATION 10.3 | — | — | 74.9 mm Hg STANDARD_DEVIATION 10.5 |
| Duration of diabetes Blood Pressure and Lipid Studies | 9.7 year STANDARD_DEVIATION 6.8 | 10.3 year STANDARD_DEVIATION 7.5 | — | — | 9.8 year STANDARD_DEVIATION 7.2 | 10.1 year STANDARD_DEVIATION 7 | 10.0 year STANDARD_DEVIATION 7.1 |
| Duration of diabetes Glycemic Control Study | — | — | 10.1 year STANDARD_DEVIATION 7.2 | 9.8 year STANDARD_DEVIATION 7.1 | — | — | 10.0 year STANDARD_DEVIATION 7.1 |
| Glycated hemoglobin Blood Pressure and Lipid Studies | 8.2 percent STANDARD_DEVIATION 1 | 8.2 percent STANDARD_DEVIATION 1 | — | — | 8.2 percent STANDARD_DEVIATION 1 | 8.4 percent STANDARD_DEVIATION 1.1 | 8.2 percent STANDARD_DEVIATION 1 |
| Glycated hemoglobin Glycemic Control Study | — | — | 8.3 percent STANDARD_DEVIATION 1 | 8.2 percent STANDARD_DEVIATION 1 | — | — | 8.2 percent STANDARD_DEVIATION 1 |
| Previous cardiovascular event Blood Pressure and Lipid Studies No previous cardiovascular event | 543 Participants | 419 Participants | — | — | 532 Participants | 467 Participants | 1961 Participants |
| Previous cardiovascular event Blood Pressure and Lipid Studies Previous cardiovascular event | 263 Participants | 197 Participants | — | — | 255 Participants | 180 Participants | 895 Participants |
| Previous cardiovascular event Glycemic Control Study No previous cardiovascular event | — | — | 984 Participants | 977 Participants | — | — | 1961 Participants |
| Previous cardiovascular event Glycemic Control Study Previous cardiovascular event | — | — | 443 Participants | 452 Participants | — | — | 895 Participants |
| Race Blood Pressure and Lipid Studies Nonwhite race | 222 Participants | 201 Participants | — | — | 234 Participants | 203 Participants | 860 Participants |
| Race Blood Pressure and Lipid Studies White race | 584 Participants | 415 Participants | — | — | 553 Participants | 444 Participants | 1996 Participants |
| Race Glycemic Control Study Nonwhite race | — | — | 433 Participants | 427 Participants | — | — | 860 Participants |
| Race Glycemic Control Study White race | — | — | 994 Participants | 1002 Participants | — | — | 1996 Participants |
| Severity of Diabetic Retinopathy Blood Pressure and Lipid Studies Mild | 141 Participants | 117 Participants | — | — | 155 Participants | 105 Participants | 518 Participants |
| Severity of Diabetic Retinopathy Blood Pressure and Lipid Studies Missing | 0 Participants | 0 Participants | — | — | 0 Participants | 2 Participants | 2 Participants |
| Severity of Diabetic Retinopathy Blood Pressure and Lipid Studies Moderate Nonproliferative Diabetic Retinopathy | 230 Participants | 198 Participants | — | — | 224 Participants | 195 Participants | 847 Participants |
| Severity of Diabetic Retinopathy Blood Pressure and Lipid Studies None | 429 Participants | 295 Participants | — | — | 398 Participants | 328 Participants | 1450 Participants |
| Severity of Diabetic Retinopathy Blood Pressure and Lipid Studies Proliferative diabetic retinopathy | 4 Participants | 5 Participants | — | — | 6 Participants | 14 Participants | 29 Participants |
| Severity of Diabetic Retinopathy Blood Pressure and Lipid Studies Severe Nonproliferative Diabetic Retinopathy | 2 Participants | 1 Participants | — | — | 4 Participants | 3 Participants | 10 Participants |
| Severity of Diabetic Retinopathy Glycemic Control Study Mild | — | — | 277 Participants | 241 Participants | — | — | 518 Participants |
| Severity of Diabetic Retinopathy Glycemic Control Study Missing | — | — | 1 Participants | 1 Participants | — | — | 2 Participants |
| Severity of Diabetic Retinopathy Glycemic Control Study Moderate Nonproliferative Diabetic Retinopathy | — | — | 404 Participants | 443 Participants | — | — | 847 Participants |
| Severity of Diabetic Retinopathy Glycemic Control Study None | — | — | 721 Participants | 729 Participants | — | — | 1450 Participants |
| Severity of Diabetic Retinopathy Glycemic Control Study Proliferative diabetic retinopathy | — | — | 19 Participants | 10 Participants | — | — | 29 Participants |
| Severity of Diabetic Retinopathy Glycemic Control Study Severe Nonproliferative Diabetic Retinopathy | — | — | 5 Participants | 5 Participants | — | — | 10 Participants |
| Sex: Female, Male Blood Pressure and Lipid Studies Female | 247 Participants | 279 Participants | — | — | 254 Participants | 310 Participants | 1090 Participants |
| Sex: Female, Male Blood Pressure and Lipid Studies Male | 559 Participants | 337 Participants | — | — | 533 Participants | 337 Participants | 1766 Participants |
| Sex: Female, Male Glycemic Control Study Female | — | — | 552 Participants | 538 Participants | — | — | 1090 Participants |
| Sex: Female, Male Glycemic Control Study Male | — | — | 875 Participants | 891 Participants | — | — | 1766 Participants |
| Smoking status Blood Pressure and Lipid Studies Current Smoker | 119 Participants | 77 Participants | — | — | 102 Participants | 89 Participants | 387 Participants |
| Smoking status Blood Pressure and Lipid Studies Former Smoker | 373 Participants | 276 Participants | — | — | 352 Participants | 279 Participants | 1280 Participants |
| Smoking status Blood Pressure and Lipid Studies Missing | 1 Participants | 0 Participants | — | — | 0 Participants | 0 Participants | 1 Participants |
| Smoking status Blood Pressure and Lipid Studies Never smoked | 313 Participants | 263 Participants | — | — | 333 Participants | 279 Participants | 1188 Participants |
| Smoking status Glycemic Control Study Current Smoker | — | — | 196 Participants | 191 Participants | — | — | 387 Participants |
| Smoking status Glycemic Control Study Former Smoker | — | — | 623 Participants | 657 Participants | — | — | 1280 Participants |
| Smoking status Glycemic Control Study Missing | — | — | 1 Participants | 0 Participants | — | — | 1 Participants |
| Smoking status Glycemic Control Study Never smoked | — | — | 607 Participants | 581 Participants | — | — | 1188 Participants |
| Systolic Blood pressure Blood Pressure and Lipid Studies | 131.5 mm Hg STANDARD_DEVIATION 17 | 139.0 mm Hg STANDARD_DEVIATION 14.7 | — | — | 131.1 mm Hg STANDARD_DEVIATION 17.5 | 138.0 mm Hg STANDARD_DEVIATION 16.7 | 134.5 mm Hg STANDARD_DEVIATION 17 |
| Systolic Blood pressure Glycemic Control Study | — | — | 134.7 mm Hg STANDARD_DEVIATION 17.4 | 134.3 mm Hg STANDARD_DEVIATION 16.6 | — | — | 134.5 mm Hg STANDARD_DEVIATION 17 |
| Triglycerides Blood Pressure and Lipid Studies | 190.1 mg/dl STANDARD_DEVIATION 111.3 | 204.7 mg/dl STANDARD_DEVIATION 240.3 | — | — | 187.9 mg/dl STANDARD_DEVIATION 112.4 | 200.7 mg/dl STANDARD_DEVIATION 175.5 | 195.1 mg/dl STANDARD_DEVIATION 162.6 |
| Triglycerides Glycemic Control Study | — | — | 194 mg/dl STANDARD_DEVIATION 167.3 | 196.1 mg/dl STANDARD_DEVIATION 157.8 | — | — | 195.1 mg/dl STANDARD_DEVIATION 162.6 |
| Urinary albumin:creatinine ratio Blood Pressure and Lipid Studies | 62.3 albumin (mg/dL): creatinin (g/dL) STANDARD_DEVIATION 180.2 | 79.2 albumin (mg/dL): creatinin (g/dL) STANDARD_DEVIATION 269.9 | — | — | 83.2 albumin (mg/dL): creatinin (g/dL) STANDARD_DEVIATION 331.5 | 62.5 albumin (mg/dL): creatinin (g/dL) STANDARD_DEVIATION 197.6 | 71.8 albumin (mg/dL): creatinin (g/dL) STANDARD_DEVIATION 253.1 |
| Urinary albumin:creatinine ratio Glycemic Control Study | — | — | 74.0 albumin (mg/dL): creatinin (g/dL) STANDARD_DEVIATION 275.3 | 69.5 albumin (mg/dL): creatinin (g/dL) STANDARD_DEVIATION 2228.9 | — | — | 71.8 albumin (mg/dL): creatinin (g/dL) STANDARD_DEVIATION 253.1 |
| Visual acuity Blood Pressure and Lipid Studies | 76.2 letters STANDARD_DEVIATION 9.7 | 75.5 letters STANDARD_DEVIATION 10.2 | — | — | 76.2 letters STANDARD_DEVIATION 10.7 | 75.6 letters STANDARD_DEVIATION 10.3 | 75.9 letters STANDARD_DEVIATION 10.2 |
| Visual acuity Glycemic Control Study | — | — | 75.9 letters STANDARD_DEVIATION 10 | 75.9 letters STANDARD_DEVIATION 10.4 | — | — | 75.9 letters STANDARD_DEVIATION 10.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy
Diabetic retinopathy status was defined according to the eye with the highest level on the ETDRS Final Severity Scale for Persons, as follows: no diabetic retinopathy, a level of less than 20; mild diabetic retinopathy, a level of 20; moderate nonproliferative diabetic retinopathy (NPDR), a level above 20 but less than 53; severe diabetic retinopathy, a level of 53 but less than 60; and proliferative diabetic retinopathy (PDR), a level of 60 or higher.
Time frame: Measured at Year 4
Population: The ACCORD Eye study recruited 3472 eligible participants. Of these, 2856 participants had both baseline and year 4 follow-up data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Glycemia Control | Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy | 104 participants |
| Standard Glycemia Control | Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy | 149 participants |
| Intensive Blood Pressure Control | Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy | 67 participants |
| Standard Blood Pressure Control | Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy | 54 participants |
| Fenofibrate + Simvastatin Therapy | Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy | 52 participants |
| Placebo + Simvastatin Therapy | Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy | 80 participants |
Comparison: Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 91% to detect a 20% relative reduction with lipid control with a statin and fenofibrate as compared with lipid control with a statin alonep-value: 0.00695% CI: [0.42, 0.87]Regression, Logistic
Comparison: Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 88% to detect a 15% relative reduction with intensive glycemic control as compared with standard glycemic controlp-value: 0.00395% CI: [0.51, 0.87]Regression, Logistic
Comparison: Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 80% to detect a 20% relative reduction with intensive blood pressure control as compared with standard blood pressure controlp-value: 0.2995% CI: [0.84, 1.79]Regression, Logistic
Secondary
Cataract Extraction
Time frame: Measured at Year 4
Population: Subset of Participants from the entire ACCORD cohort (NCT00000620) who provided information regarding whether or not they had a cataract extraction.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intensive Glycemia Control | Cataract Extraction | 547 Participants |
| Standard Glycemia Control | Cataract Extraction | 623 Participants |
| Intensive Blood Pressure Control | Cataract Extraction | 266 Participants |
| Standard Blood Pressure Control | Cataract Extraction | 300 Participants |
| Fenofibrate + Simvastatin Therapy | Cataract Extraction | 305 Participants |
| Placebo + Simvastatin Therapy | Cataract Extraction | 299 Participants |
p-value: 0.035595% CI: [0.788, 0.992]Regression, Cox
p-value: 0.1795% CI: [0.755, 1.051]Regression, Cox
p-value: 0.8695% CI: [0.865, 1.19]Regression, Cox
Secondary
Development or Progression of Macular Edema
Time frame: Measured at Year 4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intensive Glycemia Control | Development or Progression of Macular Edema | 44 Participants |
| Standard Glycemia Control | Development or Progression of Macular Edema | 40 Participants |
| Intensive Blood Pressure Control | Development or Progression of Macular Edema | 18 Participants |
| Standard Blood Pressure Control | Development or Progression of Macular Edema | 20 Participants |
| Fenofibrate + Simvastatin Therapy | Development or Progression of Macular Edema | 24 Participants |
| Placebo + Simvastatin Therapy | Development or Progression of Macular Edema | 22 Participants |
p-value: 0.06995% CI: [0.71, 1.69]Regression, Logistic
p-value: 0.6395% CI: [0.44, 1.63]Regression, Logistic
p-value: 0.7895% CI: [0.6, 1.96]Regression, Logistic
Secondary
Loss of Visual Acuity
Time frame: Measured at Year 4
Population: Subset of Participants from the entire ACCORD cohort (NCT00000620) who provided information about loss in visual acuity.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intensive Glycemia Control | Loss of Visual Acuity | 744 Participants |
| Standard Glycemia Control | Loss of Visual Acuity | 752 Participants |
| Intensive Blood Pressure Control | Loss of Visual Acuity | 367 Participants |
| Standard Blood Pressure Control | Loss of Visual Acuity | 382 Participants |
| Fenofibrate + Simvastatin Therapy | Loss of Visual Acuity | 354 Participants |
| Placebo + Simvastatin Therapy | Loss of Visual Acuity | 393 Participants |
p-value: 0.9695% CI: [0.901, 1.104]Regression, Cox
p-value: 0.595% CI: [0.825, 1.099]Regression, Cox
p-value: 0.0895% CI: [0.762, 1.016]Regression, Cox