Randomised Control Trial To Compare Central Macular Thickness(Retinal thickness) in Patients Undergoing Phacoemulsification(Phaco Cataract surgery) with or without Intravitreal Dexamethasone(steroid) Injection in Patients with Coexisting Diabetic Macular Edema(fluid in retina due to Diabetes)

To Compare Central Macular Thickness in Patients Undergoing Phacoemulsification with or without Intravitreal Dexamethasone Injection in Patients with Coexisting Diabetic Macular Edema - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/068093

Enrollment

Registered

2024-05-30

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: H36- Retinal disorders in diseases classified elsewhere

Interventions

Intervention1: Intravitreal Dexamethasone injection post Phacoemulsification: Post the Phacoemulsification Lignocaine will be instilled topically. A distance of 3.5mm shall be marked from limbus in th

Eligibility

Inclusion criteria

Inclusion criteria: 1.Type 1 and 2 Diabetes Mellitus. 2.Visual Acuity of 6/12 or less. 3.Central macular thickness of 300 microns or less. 4.Any gender.

Exclusion criteria

Exclusion criteria: 1 Any co-existing retinal pathology apart from diabetic retinopathy likely to affect visual acuity. 2 Vitrectomised Eye. 3 Uncontrolled Diabetes defined of HbA1c more than 10 percent. 4 Any intra operative or post-operative complication effecting the visual acuity.

Design outcomes

Primary

Measure	Time frame
To compare change in central macular thickness by OCTTimepoint: 1 week 1 month 2 months and 3 months	—

Secondary

Measure	Time frame
To compare change in intraocular pressure by NCT following the procedureTimepoint: at 1 week, 1 month, 2 months and 3 months follow up.	—

Countries

India

Contacts

Public ContactDr. SK Choudhary

Northern Railway Central Hospital

SHAILENDERCHOUDHARY@REDIFFMAIL.COM9717630563

Outcome results

None listed

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