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Trial record 29 of 34 for:    myopic macular degeneration

Low Vision Depression Prevention Trial for Age Related Macular Degeneration (VITAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00769015
Recruitment Status : Completed
First Posted : October 8, 2008
Results First Posted : November 20, 2014
Last Update Posted : November 20, 2014
Sponsor:
Collaborators:
Dartmouth-Hitchcock Medical Center
Johns Hopkins University
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Age-related Macular Degeneration
Depression
Interventions Behavioral: BA-LVR
Behavioral: ST-LVR
Enrollment 188
Recruitment Details Subjects were recruited from July 2009 through Feb 2013 from a large, private retina practice.
Pre-assignment Details  
Arm/Group Title BA-LVR ST-LVR
Hide Arm/Group Description

In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.

BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits

Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.

ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy

Period Title: Overall Study
Started 96 92
Completed 87 76
Not Completed 9 16
Arm/Group Title BA-LVR ST-LVR Total
Hide Arm/Group Description

In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.

BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits

Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.

ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy

Total of all reporting groups
Overall Number of Baseline Participants 96 92 188
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 96 participants 92 participants 188 participants
85.2  (6.6) 82.7  (6.9) 84.0  (6.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 92 participants 188 participants
Female
70
  72.9%
62
  67.4%
132
  70.2%
Male
26
  27.1%
30
  32.6%
56
  29.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 92 participants 188 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.0%
0
   0.0%
1
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   1.0%
2
   2.2%
3
   1.6%
White
94
  97.9%
90
  97.8%
184
  97.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 92 participants 188 participants
Hispanic or Latino
1
   1.0%
0
   0.0%
1
   0.5%
Not Hispanic or Latino
95
  99.0%
92
 100.0%
187
  99.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Depression
Hide Description The primary outcome was a DSM-IV diagnosis of major or minor depression based on the Patient Health Questionnaire-9 (PHQ-9).13 The PHQ-9 includes the 9 criteria that define DSM-IV diagnoses of depression and is valid in low-vision patients. A scoring algorithm determines whether the profile of symptoms meets categorical diagnoses of depression. The model is adjusted for treatment group, vision stratum (20/70 to 20/100 vs. < 20/100), baseline better eye scotoma size, baseline depression scores [Patient Health Questionnaire (PHQ-9)], Medical Outcome Study score (MOS-6), which is a global index of self-rated physical and mental health, and baseline neuroticism scores.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BA-LVR ST-LVR
Hide Arm/Group Description:

In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.

BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits

Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.

ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy

Overall Number of Participants Analyzed 87 76
Measure Type: Number
Unit of Measure: participants
Total Sample 11 18
Worse Vision Group (< 20/100) 5 11
Better Vision Group (20/70 to 20/100) 6 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BA-LVR, ST-LVR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .067
Comments Mantel-Haenszel chi-square test. The p-value refers to the overall test of between group differences in rates of depression.
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value .54
Confidence Interval (2-Sided) 95%
.27 to 1.06
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Vision Function: Distance Activities
Hide Description Distance vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require distance function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BA-LVR ST-LVR
Hide Arm/Group Description:

In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.

BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits

Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.

ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy

Overall Number of Participants Analyzed 87 76
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.31
(-3.25 to 3.87)
1.12
(-2.54 to 4.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BA-LVR, ST-LVR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .75
Comments [Not Specified]
Method Linear Mixed effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -.81
Confidence Interval (2-Sided) 95%
-5.92 to 4.30
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Quality of Life: Dependency
Hide Description Self-reported depencency was assessed using the Dependency subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating less dependency. Changes in least square means from baseline to 4 months are presented.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BA-LVR ST-LVR
Hide Arm/Group Description:

In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.

BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits

Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.

ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy

Overall Number of Participants Analyzed 87 76
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.07
(-4.03 to 8.18)
5.54
(-0.73 to 11.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BA-LVR, ST-LVR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .68
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Change in least squares mean
Estimated Value 3.47
Confidence Interval (2-Sided) 95%
-12.22 to 5.29
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Vision Function: Near Activities
Hide Description Near vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require near function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BA-LVR ST-LVR
Hide Arm/Group Description:

In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.

BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits

Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.

ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy

Overall Number of Participants Analyzed 87 76
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
4.78
(1.34 to 8.21)
2.36
(1.27 to 5.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BA-LVR, ST-LVR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .34
Comments [Not Specified]
Method Least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.42
Confidence Interval (2-Sided) 95%
-2.58 to 7.41
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Quality of Life: Mental Health
Hide Description Self-reported menthal health was assessed using the Mental Health subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better mental health. Changes in least square means from baseline to 4 months are presented.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BA-LVR ST-LVR
Hide Arm/Group Description:

In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.

BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits

Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.

ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy

Overall Number of Participants Analyzed 87 76
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.23
(-3.2 to 7.66)
4.25
(-1.32 to 9.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BA-LVR, ST-LVR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .68
Comments [Not Specified]
Method Least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.02
Confidence Interval (2-Sided) 95%
-9.80 to 5.76
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Quality of Life: Role Functioning
Hide Description Self-reported role functioning was assessed using the Role Difficulties subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating fewer role difficulties . Changes in least square means from baseline to 4 months are presented.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BA-LVR ST-LVR
Hide Arm/Group Description:

In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.

BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits

Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.

ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy

Overall Number of Participants Analyzed 87 76
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.33
(-1.46 to 6.12)
.93
(-2.96 to 4.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BA-LVR, ST-LVR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .68
Comments [Not Specified]
Method Least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.39
Confidence Interval (2-Sided) 95%
-4.04 to 6.82
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Quality of Life: Social Function
Hide Description Self-reported social function was assessed using the Social Functioning subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better social function. Changes in least square means from baseline to 4 months are presented.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BA-LVR ST-LVR
Hide Arm/Group Description:

In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.

BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits

Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.

ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy

Overall Number of Participants Analyzed 87 76
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-.38
(-5.59 to 3.84)
-2.00
(-7.46 to 3.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BA-LVR, ST-LVR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .68
Comments [Not Specified]
Method Least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.62
Confidence Interval (2-Sided) 95%
-5.94 to 9.17
Estimation Comments [Not Specified]
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BA-LVR ST-LVR
Hide Arm/Group Description

In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.

BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits

Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.

ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy

All-Cause Mortality
BA-LVR ST-LVR
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
BA-LVR ST-LVR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/96 (31.25%)      28/92 (30.43%)    
Cardiac disorders     
Cardiac *  2/96 (2.08%)  2 3/92 (3.26%)  3
Gastrointestinal disorders     
GI *  2/96 (2.08%)  2 2/92 (2.17%)  2
General disorders     
death NOS *  5/96 (5.21%)  5 4/92 (4.35%)  4
Metabolism and nutrition disorders     
dehydration *  1/96 (1.04%)  1 0/92 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Break/fracture *  8/96 (8.33%)  8 9/92 (9.78%)  9
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer *  3/96 (3.13%)  3 2/92 (2.17%)  2
Renal and urinary disorders     
UTI *  0/96 (0.00%)  0 1/92 (1.09%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory *  1/96 (1.04%)  1 4/92 (4.35%)  4
Vascular disorders     
Stroke/TIA *  8/96 (8.33%)  8 3/92 (3.26%)  3
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
BA-LVR ST-LVR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/96 (11.46%)      5/92 (5.43%)    
General disorders     
falls with no break/uti *  11/96 (11.46%)  11 5/92 (5.43%)  5
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Robin Casten
Organization: Thomas Jefferson University
Phone: 215-503-1250
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00769015     History of Changes
Other Study ID Numbers: 1U01EY018819 ( U.S. NIH Grant/Contract )
First Submitted: October 7, 2008
First Posted: October 8, 2008
Results First Submitted: October 9, 2014
Results First Posted: November 20, 2014
Last Update Posted: November 20, 2014