Clinical Study on Prognosis of Patients With Severe NPDR Undergoing Vitrectomy (NCT05852132) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Study on Prognosis of Patients With Severe NPDR Undergoing Vitrectomy
China249 participantsStarted 2024-05-05
Plain-language summary
To investigate the prognosis of retinal structure and function after vitrectomy in patients with severe non-proliferative diabetic retinopathy, to explore the feasibility of vitrectomy in patients with severe non-proliferative diabetic retinopathy(NPDR), and to seek the best way to delay the progression of diabetic retinopathy from the perspective of therapeutic effect.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Aged ≥18 years, men or women
✓. Severe nonproliferative diabetic retinopathy was diagnosed with any one of the following, according to the International Classification of Clinical Severity of Diabetic Retinopathy: more than 20 intraretinal hemorrhaged spots in any one of four quadrants, definite venous beading in more than two quadrants, or definite intraretinal microvascular changes in more than one quadrant.
✓. ETDRS beat corrected visual acuity(BCVA) letter score between 19 and 78 (Snellen equivalent 20/400-20/32) on the day of randomisation.
✓. At least partial corneal transparency (or central corneal transparency), good pupil dilation and full cooperation with PRP, and ensure that the fundus examination, visual function examination and optical coherence tomography (OCT) examination can be performed after vitrectomy.
✓. Able and willing to sign informed consent
Exclusion criteria
✕. Unwilling or unable to provide consent for participation in the study, unwilling to submit to the randomisation process or unable to return for the scheduled protocol visits
✕. Participating in another clinical trial within the past 3 months.
✕. Previous intraocular laser therapy, intraocular surgery (excluding cataract surgery), or scheduled to undergo surgery within the next 6 months
✕. Previous poorly controlled glaucoma (defined as intraocular pressure ≥25mmHg after anti-glaucoma medication)
✕
What they're measuring
1
Incidence of proliferative diabetic retinopathy (PDR)