Comparison of eye drops and intra-eye injection methods for pupil dilation during cataract surgery

Route-Specific Mydriatic Effects in Manual Small Incision Cataract Surgery A Quasi-Experimental Two-Arm Cohort Study with Clinical and Pharmacokinetic Correlation - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109780

Enrollment

Registered

2026-04-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: H28- Cataract in diseases classified elsewhere

Interventions

Intervention1: tropicamide + phenylephrine+ lidocaine: Tropicamide 0.02% Class: Anticholinergic, Mydriatic agent Mechanism of Action: Blocks muscarinic receptors in the iris sphincter muscle, inhibit

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient diagnosed with simple senile cataract with more than grade 1 2. Patient with pupillary dilatation of more than 6.5 mm(baseline pupil diameter=6.5mm) 3. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Complicated cataracts. 2. Ocular comorbidities such as uveitis, glaucoma. 3. Poorly dilating pupil or conditions causing miosis like horners syndrome 4. Systemic contraindications (e.g., uncontrolled hypertension, allergies to study drugs). 5. Prior ocular surgery in study eye.

Design outcomes

Primary

Measure	Time frame
Intraoperative pupil diameter (mm) and stability of mydriasisTimepoint: Primary: Pupil diameter (mm, caliper) at baseline, 15/30 minutes post-administration (topical) or post-injection (intracameral), intra-op (capsulorhexis), end of surgery	—

Secondary

Measure	Time frame
Mydriasis stability (intra-op miosis, yes/no or % constriction).Timepoint: Mydriasis stability (intra-operative miosis, yes/no or % constriction), Baseline (pre-administration) 15 minutes post-administration 30 minutes post-administration Postoperative (immediate);Intraoperative surgery time (minutes, incision to closure).Timepoint: Intraoperative surgery time (minutes, incision to closure).Baseline (pre-administration) 15 minutes post-administration 30 minutes post-administration Postoperative (immediate);Post-op complications (e.g., corneal edema, inflammation, slit-lamp grading at 24 hours, 1 week)Timepoint: Post-op complications (e.g., corneal edema, inflammation, slit-lamp grading at 24 hours);PK parameters (post-study, literature-based: Ka, F, Vd, Cl, tÂ½).Timepoint: PK parameters (post-study, literature-based: Ka, F, Vd, Cl, tÂ½).;PK-clinical correlations (e.g., Cmax vs. pupil diameter, surgery time)Timepoint: PK-clinical correlations (e.g., Cmax vs. pupil diameter, surgery time)	—

Measure

Time frame

Mydriasis stability (intra-op miosis, yes/no or % constriction).Timepoint: Mydriasis stability (intra-operative miosis, yes/no or % constriction), Baseline (pre-administration) 15 minutes post-administration 30 minutes post-administration Postoperative (immediate);Intraoperative surgery time (minutes, incision to closure).Timepoint: Intraoperative surgery time (minutes, incision to closure).Baseline (pre-administration) 15 minutes post-administration 30 minutes post-administration Postoperative (immediate);Post-op complications (e.g., corneal edema, inflammation, slit-lamp grading at 24 hours, 1 week)Timepoint: Post-op complications (e.g., corneal edema, inflammation, slit-lamp grading at 24 hours);PK parameters (post-study, literature-based: Ka, F, Vd, Cl, tÂ½).Timepoint: PK parameters (post-study, literature-based: Ka, F, Vd, Cl, tÂ½).;PK-clinical correlations (e.g., Cmax vs. pupil diameter, surgery time)Timepoint: PK-clinical correlations (e.g., Cmax vs. pupil diameter, surgery time)

—

Countries

India

Contacts

Public ContactDR SMRITI RANI

GADAG INSTITUTE OF MEDICAL SCIENCES

samritirani1996@gmail.com8825181618

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026