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Study to compare if injection of sulphur hexafluoride gas has got any benefit over injection of air in eyes undergoing vitrectomy surgery for vitreous bleed

“To compare the efficacy of 18 % Sulphur hexa fluoride gas vs air tamponade in prevention of early postoperative vitreous cavity rebleed after vitrectomy for non-resolving vitreous hemorrhage in retinal vascular diseases– a randomized control study. ? - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061340
Enrollment
78
Registered
2024-01-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H431- Vitreous hemorrhage

Interventions

Intervention1: Sulphur hexa fluoride gas: Parsplana vitrectomy with Sulphur hexa fluoride gas tamponade is used in the study group Dose - 18 percent Sulphur hexa fluoride gas, Frequency - Single inje

Sponsors

Dr Deeksha Katoch
Lead Sponsor
DR SHILPA VISWANATH
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient age > 18 years 2. Non resolving vitreous hemorrhage = 4 weeks secondary to Proliferative Diabetic Retinopathy, Retinal vasculitis, Retinal vascular occlusion 3. Media clarity grade 3 and 4 4. Grade 0-2 vitreoretinal adhesion, according to the classification system described by Ahn et al given below Grade 0 Absence of vitreoretinal adhesion Grade 1 Localized adhesion at = 3 places Grade 2 Diffuse adhesion at = 1 places or adhesion to the optic nerve, macula, and/or vascular arcades Grade 3 Extensive adhesion projecting out to the peripheral retina

Exclusion criteria

Exclusion criteria: 1. Patient with Combined Retinal Detachment 2. Vitreous adhesion > grade 2 on USG 3. Patients with history of prior vitrectomy 4. Uncooperative patients i.e., inability to co-operate for surgery under local anesthesia 5. Patients not giving consent to be included in the study 6. Patients with media clarity grade 1 or 2 or visual acuity better than 6/18 7. Inability to avoid travel to high altitude 8. Patients with Neo Vascularization of Iris / Neo Vascular Glaucoma /Other ocular diseases contributing to vision loss

Design outcomes

Primary

MeasureTime frame
resolution of vitreous haemorrhage/abscence of vitreous cavity re bleedTimepoint: 3 months

Secondary

MeasureTime frame
best corrected visual acuityTimepoint: 3 months;requirement of repeat ppv/antivegf injectionTimepoint: 3 months

Countries

India

Contacts

Public ContactDr Shilpa Viswanath

Post Graduate Institute of Medical Education and Research - Chandigarh

drdeekshakatoch@yahoo.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026