A study to find out whether vitrectomy is better than laser for diabetic patients with partial bleeding into the vitreous jelly.

Randomized control trial for comparative evaluation of sutureless vitrectomy and pan retinal photocoagulation in proliferative diabetic retinopathy with localized vitreous hemorrhage. Acronym LEVIS-Laser and early vitrectomy in diabetic retinopathy study. - LEVIS-Laser and early vitrectomy in diabetic retinopathy study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/003022

Enrollment

Registered

2011-01-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Proliferative diabetic retinopathy with localized vitreous hemorrhage. Randomized controlled trial. Health Condition 2: E103- Type 1 diabetes mellitus with ophthalmic complications

Interventions

Intervention1: Vitrectomy: 23G sutureless vitrectomy with complete removal of posterior hyaloid and endolaser with 810nm red laser spot size 500u.All vitrectomies will be performed using the Alcon acc

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria PDR + localized vitreous hemorrhage allowing visualization of >2/3rd of the fundus + with no pre-existing tractional RD

Exclusion criteria

Exclusion criteria: Exclusion criteria 1.One- eyed 2. Other concomitant eye disease likely to affect ? glaucoma, corneal opacity. 3. Patient on dialysis 4. Patient not willing to participate 5. Patients who have received an injection of anti-VEGF within the past 60 days prior to enrollment. Inclusion and exclusion criteria for participant selection, including age and sex.

Design outcomes

Primary

Measure	Time frame
Main outcome variables 1. Vision. Vision to be evaluated on LOGMAR chart and contrast sensitivity on Pelli Robson chart at every visitTimepoint: No timepoints	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactCol Dr V P Andurkar

yes

desaieyehospital@hvdeh.org20-26970043

Outcome results

None listed

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