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Hypothesis: Patients undergoing pars plana vitrectomy for the indication of diabetic vitreous hemorrhage will have a lower incidence of postoperative vitreous hemorrhaging during the 6-month trial period when vitreous substitution with 20-30% sulfur hexafluoride gas is utilized compared to vitreous substitution with balanced salt solution.
Subjects enrolled into the study are randomized into one of the ensuing treatment cohorts: Group A patients undergo vitreous substitution with 20-30% sulfur hexafluoride (SF6) gas during PPV, whereas Group B patients undergo vitreous substitution with balanced salt solution (BSS) during PPV. Simple randomization allocates patients into treatment groups during PPV. Once all relevant maneuvers are completed by the surgeon prior to vitreous substitution, a simulated coin toss program decides the vitreous substitute, and therefore which group the patient enters. Randomization intraoperatively mitigates against selection bias of utilized surgical maneuvers such as endodiathermy on the part of the surgeon and allows for subjects to not undergo randomization in cases where intraoperative retinal breaks occur that would preclude the subject from receiving vitreous substitution with BSS.
Subjects undergo data collection at 3 postoperative visits: 1) 15 +/- 5 days following PPV, 2) 40 +/- 10 days following PPV, and 3) 185 +/- 15 days following PPV. Study subjects are evaluated at non-study times at the judgment of the examiner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sulfur hexafluoride gas | Experimental | vitreous substitution with 20-30% sulfur hexafluoride gas during vitrectomy |
|
| balanced salt solution | Active Comparator | vitreous substitution with balanced salt solution during vitrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitrectomy with sulfur hexafluoride gas | Procedure | vitreous substitution with 20-30% sulfur hexafluoride gas during vitrectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative vitreous hemorrhage rate | incidence of postoperative vitreous hemorrhage between cohorts | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| unplanned vitrectomy rate | unplanned vitrectomy for the indication of postoperative vitreous hemorrhage between cohorts | 6 months |
| visual acuity | Snellen best-corrected visual acuity |
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Inclusion:
The patient has medically-managed type I or II diabetes mellitus.
The age of the patient is > 18 years old,
Snellen best-corrected visual acuity is from 20/40 to hand motions at one foot in the subject's study eye
Proliferative diabetic retinopathy with a clinically evident vitreous hemorrhage of duration of at least one month by subjective history is present in the subject's study eye.
The vitreous hemorrhage is symptomatic and primarily responsible for the patient's reduced vision in the judgement of the examiner.
Grade 0 or I vitreoretinal adhesion according to the classification system described by Ahn et al [@] in the study eye is clinically present.
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Rush, MD | panhandle eye group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Carlota Hospital | Montemorelos | Nuevo León | 67512 | Mexico |
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| ID | Term |
|---|---|
| D014821 | Vitrectomy |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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The operating surgeons did not participate in the preoperative or postoperative care of the patient, including the data collection.
| vitrectomy with balanced salt solution | Procedure | vitreous substitution with balances salt solution during vitrectomy |
|
| 6 months |