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)
• Enrollment: 87
• Locations: 48
• Duration (Months): 43.1
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0

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 Disease	Intervention/Treatment	Phase
Diabetic Retinopathy; Diabetic Macular Edema

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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	University of California, Irvine	Irvine	California	United States	92697
2	Loma Linda University Health Care, Dept. of Ophthalmology	Loma Linda	California	United States	92354
3	Southern California Desert Retina Consultants, MC	Palm Springs	California	United States	92262
4	West Coast Retina Medical Group, Inc.	San Francisco	California	United States	94107
5	Bay Area Retina Associates	Walnut Creek	California	United States	94598
6	University of Florida College of Med., Department of Ophthalmology	Jacksonville	Florida	United States	32209
7	Florida Retina Consultants	Lakeland	Florida	United States	33805
8	Sarasota Retina Institute	Sarasota	Florida	United States	34239
9	Center for Retina and Macular Disease	Winter Haven	Florida	United States	33880
10	Retina Consultants of Hawaii, Inc.	'Aiea	Hawaii	United States	96701
11	Retina Associates of Hawaii, Inc.	Honolulu	Hawaii	United States	96813
12	Raj K. Maturi, M.D., P.C.	Indianapolis	Indiana	United States	46290
13	John-Kenyon American Eye Institute	New Albany	Indiana	United States	47150
14	Paducah Retinal Center	Paducah	Kentucky	United States	42001
15	Elman Retina Group, P.A.	Baltimore	Maryland	United States	21237
16	Wilmer Eye Institute at Johns Hopkins	Baltimore	Maryland	United States	21287-9277
17	Retina Consultants of Delmarva, P.A.	Salisbury	Maryland	United States	21801
18	Joslin Diabetes Center	Boston	Massachusetts	United States	02215
19	Henry Ford Health System, Dept of Ophthalmology and Eye Care Services	Detroit	Michigan	United States	48202
20	Vitreo-Retinal Associates	Grand Rapids	Michigan	United States	49525
21	Associated Retina Consultants	Williamsburg	Michigan	United States	49690
22	Retina Center, PA	Minneapolis	Minnesota	United States	55404
23	University of Minnesota	Minneapolis	Minnesota	United States	55455
24	Barnes Retina Institute	Saint Louis	Missouri	United States	63110
25	Retina Consultants, PLLC	Slingerlands	New York	United States	12159
26	Retina-Vitreous Surgeons of Central New York, PC	Syracuse	New York	United States	13224
27	Charlotte Eye Ear Nose and Throat Assoc, PA	Charlotte	North Carolina	United States	28210
28	Horizon Eye Care, PA	Charlotte	North Carolina	United States	28211
29	Retina Associates of Cleveland, Inc.	Beachwood	Ohio	United States	44122
30	Dean A. McGee Eye Institute	Oklahoma City	Oklahoma	United States	73104
31	Retina Northwest, PC	Portland	Oregon	United States	97210
32	Casey Eye Institute	Portland	Oregon	United States	97239
33	Palmetto Retina Center	Columbia	South Carolina	United States	29169
34	Carolina Retina Center	Columbia	South Carolina	United States	29223
35	Black Hills Regional Eye Institute	Rapid City	South Dakota	United States	57701
36	Southeastern Retina Associates, PC	Kingsport	Tennessee	United States	37660
37	Southeastern Retina Associates, P.C.	Knoxville	Tennessee	United States	37909
38	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
39	West Texas Retina Consultants P.A.	Abilene	Texas	United States	79605
40	Retina Research Center	Austin	Texas	United States	78705
41	Texas Retina Associates	Dallas	Texas	United States	75231
42	Charles A. Garcia, PA & Associates	Houston	Texas	United States	77002
43	Retina and Vitreous of Texas	Houston	Texas	United States	77025
44	Texas Retina Associates	Lubbock	Texas	United States	79424
45	Valley Retina Institute	McAllen	Texas	United States	78503
46	Rocky Mountain Retina Consultants	Salt Lake City	Utah	United States	84107
47	University of Washington Medical Center	Seattle	Washington	United States	98195
48	University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service	Madison	Wisconsin	United States	53705

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

• Diabetic Retinopathy Clinical Research Network Writing Committee, Haller JA, Qin H, Apte RS, Beck RR, Bressler NM, Browning DJ, Danis RP, Glassman AR, Googe JM, Kollman C, Lauer AK, Peters MA, Stockman ME. Vitrectomy outcomes in eyes with diabetic macular edema and vitreomacular traction. Ophthalmology. 2010 Jun;117(6):1087-1093.e3. doi: 10.1016/j.ophtha.2009.10.040. Epub 2010 Mar 17.
• Flaxel CJ, Edwards AR, Aiello LP, Arrigg PG, Beck RW, Bressler NM, Bressler SB, Ferris FL 3rd, Gupta SK, Haller JA, Lazarus HS, Qin H. Factors associated with visual acuity outcomes after vitrectomy for diabetic macular edema: diabetic retinopathy clinical research network. Retina. 2010 Oct;30(9):1488-95. doi: 10.1097/IAE.0b013e3181e7974f.

• 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: Diabetic retinopathy; Diabetic macular edema; dme; vitrectomy
• Additional relevant MeSH terms: Macular Edema; Retinal Diseases; Diabetic Retinopathy; Edema

Study Results

Participant Flow

Arm/Group Title	Diabetic Macular Edema and Vitreomacular Traction
Arm/Group Description	The 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
STARTED	87
COMPLETED	81
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Diabetic Macular Edema and Vitreomacular Traction
Arm/Group Description	The 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 Participants	87
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

Title	Visual Acuity
Description	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.
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetic Macular Edema and Vitreomacular Traction
Arm/Group Description	The 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 Participants	87
Median (Inter-Quartile Range) [Units on a scale]	52

2. Primary Outcome

Title	Change in Optical Coherence Tomography Measured Central Subfield Thickness From Baseline
Description	Change in central subfield thickness is followup central subfield retinal thickness minus baseline thickness.
Time Frame	Baseline to 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetic Macular Edema and Vitreomacular Traction
Arm/Group Description	The 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 Participants	87
Median (Inter-Quartile Range) [microns]	-160

3. Secondary Outcome

Title	Surgical Complications From Baseline to Six Months
Description	Including intraoperative and perioperative medical complications. Same subject could have more than one complication
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetic Macular Edema and Vitreomacular Traction
Arm/Group Description	The 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 Participants	87
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

Title	Percent of Participants With Change in Visual Acuity From Baseline to Six Months
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetic Macular Edema and Vitreomacular Traction
Arm/Group Description	The 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 Participants	87
Percent with 10 or more letter imporvement	38 43.7%
Percent with 10 or more letters worsening	22 25.3%

5. Primary Outcome

Title	Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 6 Months
Description	Change in thickness is followup thickness minus baseline thickness.
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetic Macular Edema and Vitreomacular Traction
Arm/Group Description	The 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 Participants	87
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

Arm/Group Title	Diabetic Macular Edema and Vitreomacular Traction
Arm/Group Description	The 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
Total	4/87 (4.6%)
Eye disorders
retinal detachment	3/87 (3.4%)
Endophthalmitis	1/87 (1.1%)
Other (Not Including Serious) Adverse Events
	Diabetic Macular Edema and Vitreomacular Traction
	Affected / at Risk (%)	# Events
Total	12/87 (13.8%)
Eye disorders
Vitreous haemorrhage	5/87 (5.7%)
Additional vitreomacular interface abnormalities	2/87 (2.3%)
Elevated intraocular pressure requirering treatment	7/87 (8%)
Double Vision	2/87 (2.3%)
Lamella hole	1/87 (1.1%)
Choroidal effusion	1/87 (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.