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Table 1 Schedule

From: Microinvasive pars plana vitrectomy combined with internal limiting membrane peeling versus anti-VEGF intravitreal injection for treatment-naïve diabetic macular edema (VVV-DME study): study protocol for a randomized controlled trial

 

Study period

 

Enrollment

Allocation

Post-allocation

Close-out

Time point

T1

0

T0

T*1(1d)

T*2(1w)

T3(1 m)

T**4(2 m)

T5(3 m)

T6(6 m)

T7(12 m)

Tx

Enrollment:

 Eligibility screen

X

          

 Informed consent

X

          

 Allocation

 

X

         

Interventions:

 PPV

  

X

        

 IVC

  

X

  

X

X

    

Assessments:

 Demographics data

X

          

 Medical history

X

          

 Laboratory examination

X

          

 Eye examination

X

  

X

X

X

X

X

X

X

 

 BCVA

X

    

X

 

X

X

X

 

 IOP

X

  

X

X

X

X

X

X

X

 

 OCT

X

    

X

 

X

X

X

 

 OCTA

X

      

X

X

X

 

Direct medical cost

         

X

 

 NEI-VFQ-25

X

       

X

X

 

 Adverse events

  

X

X

X

X

X

X

X

X

 
  1. PPV, pars plana vitrectomy; IVC, conbercept intravitreal injection; BCVA, best corrected visual acuity; IOP, intraocular pressure; OCT, optical coherence tomography; OCTA, OCT angiography; d, day; w, week; m, month
  2. *Only study group
  3. **Only control group