Vitrectomy-D: Evaluation of Vitrectomy for Diabetic Macular Edema

Sponsor
Jaeb Center for Health Research (Other)
Overall Status
Completed
CT.gov ID
NCT00709319
Collaborator
National Eye Institute (NEI) (NIH)
87
Enrollment
48
Locations
43.1
Duration (Months)
1.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is designed as a prospective cohort study to assess changes in visual acuity and retinal thickening and surgical complications in subjects undergoing vitrectomy for diabetic macular edema.

The study also aims to identify subgroups in which there appears to be a benefit of vitrectomy and subgroups in which vitrectomy does not appear to be beneficial and to obtain data that can be used to plan a randomized trial.

Subject will be followed through 2 years, with a primary outcome at 6 months post vitrectomy surgery. The vitrectomy procedure will be performed based on the investigators usual care and is not considered part of the research although the procedure performed will be collected.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    Study Design The study is designed as a prospective cohort study. A randomized trial design was considered but rejected after deciding that there was insufficient equipoise on the part of the investigator group to randomize eyes with DME and vitreal traction to surgery or no surgery (thus eyes which potentially may benefit most from vitrectomy would not be included), and there was insufficient information available on the natural course or surgical outcomes of eyes with DME but without significant traction.

    A cohort study provides the opportunity to collect data prospectively using a standardized protocol to assess the potential benefits and risks of vitrectomy. The results can be used to determine whether proceeding with a randomized trial has merit and what the design of the trial should be. If a randomized trial is to be conducted, the results plus the cohort study experience can be used to help design the protocol.

    Study Objectives

    1. To provide information on the following outcomes in eyes with Diabetic Macular Edema (DME) that undergo vitrectomy: visual acuity, retinal thickening, resolution of traction (if present), surgical complications.

    2. To identify subgroups in which there appears to be a benefit of vitrectomy and subgroups in which vitrectomy does not appear to be beneficial.

    3. To obtain data that can be used to plan a randomized trial.

    1. Intervention Vitrectomy performed by the investigator's usual routine.

    2. Duration of Follow-Up: Two years

    3. Follow-up Visit Schedule Study visits for data collection at 3 and 6 months then 1, and 2 years. Additional visits follow investigator's usual routine.

    E. Rationale:

    There are at least two avenues of investigation that support the theoretical value of vitrectomy for the treatment of DME, based on (1) vitrectomy for the relief of traction on the macula and (2) vitrectomy to improve oxygenation of the macula leading to decreased permeability with subsequent resolution or decrease in DME.

    Vitrectomy to relieve biomechanical traction on the macula has been reported widely. Schepens and coworkers discussed the role of the vitreous and vitreomacular traction in cystoid macular edema in 1984. Nasrallah et al observed in 1988 the resolution of diabetic macular edema in individuals with spontaneous separation of the vitreous gel from the retina. In 1992, Lewis and coworkers reported success with vitrectomy and peeling of a "thickened hyaloid membrane" in eyes with DME that had this anatomical feature. Since this report of a nonrandomized retrospective case series, other authors have prospectively analyzed their series and supported the concept that relief of clear-cut anteroposterior traction, usually in the setting of an epiretinal membrane complex and associated vitreous adherence, may ameliorate macular thickening and edema in DME. Evaluation of these individuals and documentation of pre and postoperative characteristics have been rendered vastly more objective by ocular coherence tomography and the Retina Thickness Analyzer. Series using optical coherence tomography (OCT) to image cases where vitreomacular traction is observed and in some cases treated, has confirmed the clinical impression of mechanical forces at work on the posterior retina and has documented the anatomic improvement with surgery. How and in which cases OCT could refine our ability to diagnose and define clinically important anatomical features or relationships has not been investigated. As Kaiser and coworkers have documented, the OCT findings in the cases that have thus far come to vitrectomy in these situations support a conclusion that the disease process has progressed very far and in many cases the individuals have actual traction retinal detachments in their maculae. These severe cases are the exception in the spectrum of DME: most cases of macular edema have no obvious vitreomacular traction, but this factor has not been investigated adequately with our newer and more sophisticated imaging techniques. It is possible that subclinical traction on the macula exists in a large number of individuals with diabetes, whose internal limiting membranes at the vitreomacular interface often have a thickened, hypercellular appearance and whose vitreous gels, gradually contracting over many years, may exert subclinical but significant traction on the compromised diabetic macular vascular bed.

    The other line of reasoning and prior research that supports the possibility that vitrectomy would help DME is that articulated by Steffanson and others indicating that posterior segment oxygenation improves after vitrectomy. Using oxygen sensors on the retinal surface, these investigators have shown that retinal oxygen tensions increase after the vitreous gel is removed and the posterior segment becomes perfused by relatively oxygen-rich aqueous humor. Supporting this conclusion is the additional observation that retinal vessels decrease in caliber after vitrectomy, presumably in response to the improvement in hypoxia, although confounding factors that could contribute to this decrease, such as the addition of endolaser retinal photocoagulation, have not been ruled out. Numerous lines of investigation have elucidated factors producing permeability in retinal blood vessels. One of the most central of these factors is Vascular Endothelial Growth factor (VEGF), formerly known as Vascular Permeability Factor (VPF). VEGF is known to be upregulated by hypoxia, and downregulated by increased oxygenation. The speculated sequence of events in which vitrectomy produces improved oxygenation of the posterior segment, leading to downregulation of VEGF, leading to decreased vasopermeability, resulting in reduced macular thickening, is a plausible one. More rapid clearing of growth factors in the vitrectomized eye has also been postulated as a potential mechanism for this response.

    See full protocol at drcr.net for list of references

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    87 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Vitrectomy for Diabetic Macular Edema Study
    Study Start Date :
    Jul 1, 2005
    Actual Primary Completion Date :
    Aug 1, 2008
    Actual Study Completion Date :
    Feb 1, 2009

    Arms and Interventions

    ArmIntervention/Treatment
    Primary

    Subjects vitreomacular traction, visual acuity 20/63 to 20/400, retinal thickness >300 microns in the central subfield on OCT, and cataract extraction not being performed in conjunction with vitrectomy.

    Outcome Measures

    Primary Outcome Measures

    1. Visual Acuity [Baseline to 6 months]

      Change in best correct visual acuity letter score from baseline to six months as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.

    2. Change in Optical Coherence Tomography Measured Central Subfield Thickness From Baseline [Baseline to 6 Months]

      Change in central subfield thickness is followup central subfield retinal thickness minus baseline thickness.

    3. Percent of Participants With Change in Visual Acuity From Baseline to Six Months [Baseline to 6 months]

    4. Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 6 Months [Baseline to 6 months]

      Change in thickness is followup thickness minus baseline thickness.

    Secondary Outcome Measures

    1. Surgical Complications From Baseline to Six Months [Baseline to 6 months]

      Including intraoperative and perioperative medical complications. Same subject could have more than one complication

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Subject-level Inclusion Criteria

    To be eligible, the following inclusion criteria (1-3) must be met:
    1. Age >= 18 years

    2. Diagnosis of diabetes mellitus (type 1 or type 2)

    3. Able and willing to provide informed consent.

    Subject-level Exclusion Criteria

    A patient is not eligible if any of the following exclusion criteria (4-6) are present:

    1. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).

    2. Patient is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first year of the study.

    3. Blood pressure >180/110 (systolic above 180 OR diastolic above 110).

    Study Eye Criteria

    To be a study eye, all of the inclusion criteria (a-e) and none of the exclusion criteria (f-m) listed below must be met. A patient can have only one study eye. If both eyes are eligible and undergoing vitrectomy, the first eye having surgery will be the study eye.

    The eligibility criteria for a study eye are as follows:

    Inclusion

    1. Vitrectomy being performed as treatment for DME.

    2. E-ETDRS visual acuity 20/800 or better (E-ETDRS visual acuity score >= 3 letters).

    3. Definite retinal thickening due to diabetic macular edema based on clinical exam involving the center of the macula.

    4. Presence of vitreomacular traction associated with macular edema OR edema is felt to be too diffuse to respond to focal or grid laser OR edema judged to be inadequately responsive to previous treatment(s) and unlikely to benefit from further focal photocoagulation.

    5. Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.

    Exclusion

    1. Macular edema is considered to be due to a cause other than diabetic macular edema.

    2. An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary abnormalities, subfoveal hard exudates, fibrous metaplasia, nonretinal condition).

    3. An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, post-surgical cystoid macular edema, etc.).

    4. History of retinal macular photocoagulation, intravitreal corticosteroids, or other treatment for DME within 3.5 months prior to enrollment.

    5. History of peripheral scatter photocoagulation within 4 months prior to enrollment or anticipated need within the 4 months following enrollment.

    6. History of prior pars plana vitrectomy.

    7. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 6 months or anticipated within the next 6 months following enrollment.

    8. History of YAG capsulotomy performed within 2 months prior to enrollment.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of California, IrvineIrvineCaliforniaUnited States92697
    2Loma Linda University Health Care, Dept. of OphthalmologyLoma LindaCaliforniaUnited States92354
    3Southern California Desert Retina Consultants, MCPalm SpringsCaliforniaUnited States92262
    4West Coast Retina Medical Group, Inc.San FranciscoCaliforniaUnited States94107
    5Bay Area Retina AssociatesWalnut CreekCaliforniaUnited States94598
    6University of Florida College of Med., Department of OphthalmologyJacksonvilleFloridaUnited States32209
    7Florida Retina ConsultantsLakelandFloridaUnited States33805
    8Sarasota Retina InstituteSarasotaFloridaUnited States34239
    9Center for Retina and Macular DiseaseWinter HavenFloridaUnited States33880
    10Retina Consultants of Hawaii, Inc.'AieaHawaiiUnited States96701
    11Retina Associates of Hawaii, Inc.HonoluluHawaiiUnited States96813
    12Raj K. Maturi, M.D., P.C.IndianapolisIndianaUnited States46290
    13John-Kenyon American Eye InstituteNew AlbanyIndianaUnited States47150
    14Paducah Retinal CenterPaducahKentuckyUnited States42001
    15Elman Retina Group, P.A.BaltimoreMarylandUnited States21237
    16Wilmer Eye Institute at Johns HopkinsBaltimoreMarylandUnited States21287-9277
    17Retina Consultants of Delmarva, P.A.SalisburyMarylandUnited States21801
    18Joslin Diabetes CenterBostonMassachusettsUnited States02215
    19Henry Ford Health System, Dept of Ophthalmology and Eye Care ServicesDetroitMichiganUnited States48202
    20Vitreo-Retinal AssociatesGrand RapidsMichiganUnited States49525
    21Associated Retina ConsultantsWilliamsburgMichiganUnited States49690
    22Retina Center, PAMinneapolisMinnesotaUnited States55404
    23University of MinnesotaMinneapolisMinnesotaUnited States55455
    24Barnes Retina InstituteSaint LouisMissouriUnited States63110
    25Retina Consultants, PLLCSlingerlandsNew YorkUnited States12159
    26Retina-Vitreous Surgeons of Central New York, PCSyracuseNew YorkUnited States13224
    27Charlotte Eye Ear Nose and Throat Assoc, PACharlotteNorth CarolinaUnited States28210
    28Horizon Eye Care, PACharlotteNorth CarolinaUnited States28211
    29Retina Associates of Cleveland, Inc.BeachwoodOhioUnited States44122
    30Dean A. McGee Eye InstituteOklahoma CityOklahomaUnited States73104
    31Retina Northwest, PCPortlandOregonUnited States97210
    32Casey Eye InstitutePortlandOregonUnited States97239
    33Palmetto Retina CenterColumbiaSouth CarolinaUnited States29169
    34Carolina Retina CenterColumbiaSouth CarolinaUnited States29223
    35Black Hills Regional Eye InstituteRapid CitySouth DakotaUnited States57701
    36Southeastern Retina Associates, PCKingsportTennesseeUnited States37660
    37Southeastern Retina Associates, P.C.KnoxvilleTennesseeUnited States37909
    38Vanderbilt University Medical CenterNashvilleTennesseeUnited States37232
    39West Texas Retina Consultants P.A.AbileneTexasUnited States79605
    40Retina Research CenterAustinTexasUnited States78705
    41Texas Retina AssociatesDallasTexasUnited States75231
    42Charles A. Garcia, PA & AssociatesHoustonTexasUnited States77002
    43Retina and Vitreous of TexasHoustonTexasUnited States77025
    44Texas Retina AssociatesLubbockTexasUnited States79424
    45Valley Retina InstituteMcAllenTexasUnited States78503
    46Rocky Mountain Retina ConsultantsSalt Lake CityUtahUnited States84107
    47University of Washington Medical CenterSeattleWashingtonUnited States98195
    48University of Wisconsin-Madison, Dept of Ophthalmology/Retina ServiceMadisonWisconsinUnited States53705

    Sponsors and Collaborators

    • Jaeb Center for Health Research
    • National Eye Institute (NEI)

    Investigators

    • Study Chair: Julia A. Haller, M.D., Wills Eye Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jaeb Center for Health Research
    ClinicalTrials.gov Identifier:
    NCT00709319
    Other Study ID Numbers:
    • NEI-125
    • U10EY018817-03
    • U10EY014229-07
    • U10EY014231-09
    First Posted:
    Jul 3, 2008
    Last Update Posted:
    Oct 7, 2019
    Last Verified:
    Sep 1, 2019
    Keywords provided by Jaeb Center for Health Research
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleDiabetic Macular Edema and Vitreomacular Traction
    Arm/Group DescriptionThe primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
    Period Title: Overall Study
    STARTED87
    COMPLETED81
    NOT COMPLETED6

    Baseline Characteristics

    Arm/Group TitleDiabetic Macular Edema and Vitreomacular Traction
    Arm/Group DescriptionThe primary cohort included 87 eyes with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year. Only one eye per participant could be enrolled.
    Overall Participants87
    Age, Customized (Years) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [Years]
    66
    Sex: Female, Male (Count of Participants)
    Female
    39
    44.8%
    Male
    48
    55.2%
    Race/Ethnicity, Customized (participants) [Number]
    White
    69
    79.3%
    African American
    7
    8%
    Hispanic
    5
    5.7%
    Other
    6
    6.9%
    Surgery characteristic: Focal/grid laser to diabetic macular edema used (Number) [Number]
    Yes
    4
    4.6%
    No
    83
    95.4%
    Surgery characteristic: Panretinal photocoagulation, history of prior use (Number) [Number]
    Yes
    16
    18.4%
    No
    71
    81.6%
    Indocyanine green used to improve visualization (Number) [Number]
    Yes
    24
    27.6%
    No
    63
    72.4%
    Diabetes Type (Number) [Number]
    Type 1
    14
    16.1%
    Type 2
    73
    83.9%
    Epiretinal Membranes Present (Number) [Number]
    No
    21
    24.1%
    Probable
    19
    21.8%
    Definite
    43
    49.4%
    Can not deterimine
    4
    4.6%
    Lens Status (Number) [Number]
    Phakic
    37
    42.5%
    Pseudophakic/aphakic
    50
    57.5%
    Prior Scatter Photocoagulation (Number) [Number]
    Yes
    39
    44.8%
    No
    48
    55.2%
    Prior Treatment for Diabetic Macular Edema (Number) [Number]
    Yes
    51
    58.6%
    No
    36
    41.4%
    Reasons for Vitrectomy: Vitreomacular interface abnormality (Number) [Number]
    Number [Participants]
    87
    100%
    Retinopathy Severity (Number) [Number]
    Microaneurysms only
    1
    1.1%
    Mild/moderate nonproliferative diabetic retinopath
    6
    6.9%
    Moderate/severe nonproliferative diabetic retinopa
    14
    16.1%
    Severe nonproliferative diabetic retinopathy
    4
    4.6%
    Proliferative diabetic retinopathy
    51
    58.6%
    Retinal volume not obtained
    11
    12.6%
    Status of the Vitreous (Number) [Number]
    Attached
    49
    56.3%
    Partially Attached
    28
    32.2%
    Detached
    5
    5.7%
    Uncertain
    5
    5.7%
    Triamcinolone acetonide used to improve visualization (Number) [Number]
    Yes
    30
    34.5%
    No
    57
    65.5%
    Surgical Characteristic: Internal Limiting Membrane Removed (Number) [Number]
    Yes
    47
    54%
    No
    40
    46%
    Surgical Characteristic: Focal to grid breaks Laser Used (Number) [Number]
    Yes
    14
    16.1%
    No
    73
    83.9%
    Surgical Characteristic: Vitrectomy System (Number) [Number]
    19/20 gauge
    35
    40.2%
    25 gauge
    43
    49.4%
    23 gauge
    9
    10.3%
    Surgical Charachteristic:Epiretinal membrane peeled (Number) [Number]
    Yes
    53
    60.9%
    No
    34
    39.1%
    Central Subfield Thickness (Microns) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [Microns]
    491
    Duration of Diabetes (Years) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [Years]
    20
    Electronic-Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score (Number on a Scale) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [Number on a Scale]
    52
    Hemoglobin A1c (Percent) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [Percent]
    7.1
    Retinal Volume (mm3) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [mm3]
    9.2
    Reasons for Vitrectomy: Unresponsive to other therapies (Number) [Number]
    Yes
    27
    31%
    No
    60
    69%
    Trypan blue used to improve visualization (Number) [Number]
    Yes
    2
    2.3%
    No
    85
    97.7%
    Surgery characteristic: Panretinal photocoagulation, with none used prior (Number) [Number]
    Yes
    19
    21.8%
    No
    68
    78.2%
    Surgery characteristic: Laser used with endoprobe (Number) [Number]
    Yes
    21
    24.1%
    No
    66
    75.9%
    Surgery characteristic: Laser used with indirect ophthalmoscope (Number) [Number]
    Yes
    7
    8%
    No
    80
    92%
    Surgery characteristic: Scatter laser over peripheral schisis or barrier laser used (Number) [Number]
    Yes
    4
    4.6%
    No
    83
    95.4%

    Outcome Measures

    1. Primary Outcome
    TitleVisual Acuity
    DescriptionChange in best correct visual acuity letter score from baseline to six months as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
    Time FrameBaseline to 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleDiabetic Macular Edema and Vitreomacular Traction
    Arm/Group DescriptionThe primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
    Measure Participants87
    Median (Inter-Quartile Range) [Units on a scale]
    52
    2. Primary Outcome
    TitleChange in Optical Coherence Tomography Measured Central Subfield Thickness From Baseline
    DescriptionChange in central subfield thickness is followup central subfield retinal thickness minus baseline thickness.
    Time FrameBaseline to 6 Months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleDiabetic Macular Edema and Vitreomacular Traction
    Arm/Group DescriptionThe primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
    Measure Participants87
    Median (Inter-Quartile Range) [microns]
    -160
    3. Secondary Outcome
    TitleSurgical Complications From Baseline to Six Months
    DescriptionIncluding intraoperative and perioperative medical complications. Same subject could have more than one complication
    Time FrameBaseline to 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleDiabetic Macular Edema and Vitreomacular Traction
    Arm/Group DescriptionThe primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
    Measure Participants87
    Total
    16
    18.4%
    Vitreous hemorrhage
    5
    5.7%
    Additional vitreomacular interface abnormalities
    2
    2.3%
    Elevated intraocular pressure requiring treatment
    7
    8%
    Retinal Detachment
    3
    3.4%
    Endophthalmitis
    1
    1.1%
    Double vision
    2
    2.3%
    Lamella hole
    1
    1.1%
    Choroidal effusion
    1
    1.1%
    Other
    2
    2.3%
    4. Primary Outcome
    TitlePercent of Participants With Change in Visual Acuity From Baseline to Six Months
    Description
    Time FrameBaseline to 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleDiabetic Macular Edema and Vitreomacular Traction
    Arm/Group DescriptionThe primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
    Measure Participants87
    Percent with 10 or more letter imporvement
    38
    43.7%
    Percent with 10 or more letters worsening
    22
    25.3%
    5. Primary Outcome
    TitleChange in Optical Coherence Tomography Central Subfield Thickness From Baseline to 6 Months
    DescriptionChange in thickness is followup thickness minus baseline thickness.
    Time FrameBaseline to 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleDiabetic Macular Edema and Vitreomacular Traction
    Arm/Group DescriptionThe primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
    Measure Participants87
    Central subfield decrease of 100 microns or more
    49
    56.3%
    Central subfield decrease of 50 microns or more
    61
    70.1%
    Central subfield increase of 50 microns or more
    3
    3.4%
    Central subfield thickening decrease of >=50%
    50
    57.5%
    Central subfield less than 250 microns at 6 months
    33
    37.9%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group TitleDiabetic Macular Edema and Vitreomacular Traction
    Arm/Group DescriptionThe primary cohort included 87 eyes with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year. Only one eye per participant could be enrolled.
    All Cause Mortality
    Diabetic Macular Edema and Vitreomacular Traction
    Affected / at Risk (%)# Events
    Total/ (NaN)
    Serious Adverse Events
    Diabetic Macular Edema and Vitreomacular Traction
    Affected / at Risk (%)# Events
    Total4/87 (4.6%)
    Eye disorders
    retinal detachment3/87 (3.4%)
    Endophthalmitis1/87 (1.1%)
    Other (Not Including Serious) Adverse Events
    Diabetic Macular Edema and Vitreomacular Traction
    Affected / at Risk (%)# Events
    Total12/87 (13.8%)
    Eye disorders
    Vitreous haemorrhage5/87 (5.7%)
    Additional vitreomacular interface abnormalities2/87 (2.3%)
    Elevated intraocular pressure requirering treatment7/87 (8%)
    Double Vision2/87 (2.3%)
    Lamella hole1/87 (1.1%)
    Choroidal effusion1/87 (1.1%)

    Limitations/Caveats

    [Not Specified]

    More Information

    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/TitleAdam R. Glassman, Director DRCR.net Coordinating Center
    OrganizationJaeb Center for Health Research
    Phone813-975-8690
    Emaildrcrstat3@jaeb.org
    Responsible Party:
    Jaeb Center for Health Research
    ClinicalTrials.gov Identifier:
    NCT00709319
    Other Study ID Numbers:
    • NEI-125
    • U10EY018817-03
    • U10EY014229-07
    • U10EY014231-09
    First Posted:
    Jul 3, 2008
    Last Update Posted:
    Oct 7, 2019
    Last Verified:
    Sep 1, 2019