To study the Pupil Constriction in Femto-Second Laser-Assisted Cataract Surgery (FLACS) vs Intravenous steroid, dexamethasone Injection before surgery.

Comparative Analysis of Pupillary Constriction in Femto-Second Laser-Assisted Cataract Surgery (FLACS) vs Pre-Operative Intravenous Dexamethasone Injection: A Prospective Randomized Study - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085622

Enrollment

280

Registered

2025-04-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: H258- Other age-related cataract

Interventions

Intervention1: Comparative Analysis of Pupillary Constriction in Femto-Second Laser-Assisted Cataract Surgery (FLACS): To study the effect of pre operative intravenous dexamethasone on pupil size afte

Eligibility

Inclusion criteria

Inclusion criteria: Patient with cataract grade less than or equal to LOCS NO 1-4, CC 1-5, PSC 1-5. Patients with cataract with a stable refractive error. Patient with no significant coexisting ocular pathology. Patients with cataract with no history of previous ocular surgeries. Patients with cataract with a normal pupillary reaction and no history of known pupillary abnormalities. Patient with cataract with well dilating pupil (greater than or equal to 8mm)

Exclusion criteria

Exclusion criteria: Known hypersensitivity or contraindication to corticosteroids, including dexamethasone. Patients with uncontrolled systemic diseases. Patients with ocular pathologies that could interfere with the study outcomes. Patient with pupillary disorder or poorly dilating pupil (less than 8mm) Pregnant or breastfeeding women. Any condition that could result in difficulty in performing FLACS. Patients planned for a combined procedure. Patient with mature, intumescent cataract. Patient with diabetes.

Design outcomes

Primary

Measure	Time frame
Comparative Analysis of Pupillary Constriction in Femto-Second Laser-Assisted Cataract Surgery (FLACS) vs Pre-Operative Intravenous Dexamethasone Injection:Timepoint: post day 1,15 and 3 month	—

Secondary

Measure	Time frame
To compare the degree of pupillary constriction in patients undergoing Femto-Second Laser-Assisted Cataract Surgery with and without the administration of pre operative intravenous injection of dexamethasone.Timepoint: post day 1,15 and 3 month	—

Countries

India

Contacts

Public ContactDr Sristi Shreya Malakar

Nethradhama Superspeciality Eye Hospital

sush.samak@gmail.com9448071800

Outcome results

None listed

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