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A comparative study of different infusion systems and phacoemulsification tips for cataract surgery

EFFECT OF IOP BASED INFUSION SYSTEM WITH OR WITHOUT BALANCED PHACO TIP ON CUMULATIVE DISSIPATED ENERGY AND ESTIMATED FLUID USAGE IN COMPARISON TO GRAVITY FED INFUSION SYSTEM IN TORSIONAL PHACOEMULSIFICATION

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/06/007022
Enrollment
126
Registered
2016-06-14
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- CATARACT

Interventions

Intervention1: Group B: Torsional phacoemulsification using miniflare tip with IOP fed infusion system Intervention2: Group C: Torsional phacoemulsification using balanced tip with IOP fed infusion sy

Sponsors

PGIMER RML Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Grade 4.0-6.9 (LOCS III grading) of senile cataract 2. Willing and able to understand /sign a written informed consent document 3. Willing and able to return for scheduled follow-up examinations.

Exclusion criteria

Exclusion criteria: 1) Patients with pre-operative endothelial cell density count less than 1500 cells/mm2 2) All eye pathologies that can compromise the visual recovery 3) Eyes with any kind of corneal dystrophy or corneal scars preventing visualisation of cataract for reliable grading 4) Subluxated or dislocated lens 5) Raised intraocular pressure ( > 21 mmHg) 6) Previous intraocular surgery

Design outcomes

Primary

MeasureTime frame
Cumulative dissipated energy (CDE)Timepoint: PEROPERATIVE

Secondary

MeasureTime frame
Central Corneal ThicknessTimepoint: Baseline 1 month 3months 6months;Coefficient of variation of cell sizeTimepoint: Baseline 1 month 3months 6months;Endothelial cell densityTimepoint: Baseline Baseline 1 month 3months 6months ;Estimated fluid volume usageTimepoint: Peroperative;Percent HexagonalityTimepoint: Baseline 1 month 3months 6months;Total aspiration timeTimepoint: peroperative;Visual AcuityTimepoint: Baseline One Month

Countries

India

Contacts

Public ContactEkta Sain

PGIMER & RMLHospital

tarudewan@hotmail.com9810673180

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 9, 2026