Outcomes of Early surgery to clear out the bleeding in the Eye caused by Diabtetes

Not Applicable

• Conditions: Health Condition 1: H00-H59- Diseases of the eye and adnexa

• Registration Number: CTRI/2022/08/044623
• Lead Sponsor: Sankara eye hospital Guntur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age � 18 years

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

3. Vitreous haemorrhage (VH) in a patient with Proliferative Diabetic Retinopathy (PDR) causing vision impairment of duration less than one month, for which intervention is deemed necessary.

4. Patients who are willing and able to undergo vitrectomy within 2 weeks of presentation.

5. Visual acuity ranging between PL and ETDRS logMAR 0.3 (Snellenââ?¬•s equivalent of 20/40 or 6/12).

Exclusion Criteria

1. Any condition that precludes the participant from undergoing elective vitrectomy surgery in the study(e.g., unstable medical status including chronic renal failure requiring dialysis, blood pressure > 180/110, cardiovascular disease, pregnancy or lactation).

2. Systemic anti-VEGF or pro-vascular endothelial growth factor treatment within 4 months, intravitreal anti-VEGF in the study eye within 2 months of current vitreous haemorrhage onset, or intraocular corticosteroid treatment in the study eye within 4 months of current vitreous haemorrhage onset.

3. Participation in an investigational trial within 30 days that involves any drug that has not received regulatory approval for the indication being studied.� 

4. Potential participant is expected to lose follow-ups due to various reasons.

5. Evidence of traction or rhegmatogenous retinal detachment involving or threatening the macula. If the density of the haemorrhage precludes a visual assessment on the clinical exam to confirm eligibility, then it is recommended that the assessment be performed with ultrasound as standard care.

6. Evidence of uncontrolled glaucoma.

7. History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, YAG capsulotomy etc.) within 4 months or major ocular surgery other than vitrectomy anticipated within the next 6 months in the study eye.

8. Aphakia.

9. The evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To record the visual acuity in patients undergoing early vitrectomy.Timepoint: 18 months

Secondary Outcome Measures

Name	Time	Method
To assess the incidence of rebleeding after performing an early vitrectomy. <br/ ><br>To analyse the impact of early vitrectomy on the progression of PDR - the new areas of Neovascularisation of retina elsewhere (NVE) or Fibro Vascular Proliferation (FVP).Timepoint: 18 months