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Comparative study to see the effect of intracameral mydriatics versus topical mydriatics in pupil dilatation for phacoemulsification cataract surgery.

COMPARATIVE STUDY TO SEE THE EFFECT OF INTRACAMERAL MYDRIATICS VERSUS TOPICAL MYDRIATICS IN PUPIL DILATATION FOR PHACOEMULSIFICATION CATARACT SURGERY - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/069852
Enrollment
60
Registered
2024-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: H251- Age-related nuclear cataract

Interventions

Intervention1: Intracameral injection of fixed dose combination (FDC) of mydriatics for pupil dilation: drug and dose - A FDC mixture of 0.2 % tropicamide and 2% phenylephrine and 1% preservative free

Sponsors

Shivi Srivastava
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Ability to give informed consent Planned clear cornea cataract extraction and placement of foldable posterior chamber intraocular lens No secondary procedure planned (i.e. trabeculectomy, keratectomy, corneal transplant, vitreo-retinal procedure etc.) No history of previous intraocular surgery in the eye of interest.

Exclusion criteria

Exclusion criteria: Previous or concurrent use of alpha-antagonist medication Progressive corneal pathology affecting pupil magnification or measurement Uncontrolled hypertension Allergy to the drug used Complicated cataract Pseudoexfoliation and exfoliation syndromes History of ocular trauma or inflammation in the previous 3 months

Design outcomes

Primary

MeasureTime frame
Pupil size in front of the slit lamp and by surgical callipers 3 times during the procedureTimepoint: Baseline on Pre-operative evaluation day, On the operating table after betadine wash, Before initiating capsulorhexis, At the end of the surgery

Secondary

MeasureTime frame
1. Blood pressure 2. Pulse rate Timepoint: Both will be measured thrice Peri-operatively by digital BP machine in supine position on the left upper arm of the patient at the level of the heart. Baseline on Pre-operative evaluation day, 10mins before the surgery, Immediate post-operative period, On post-operative Day 1

Countries

India

Contacts

Public ContactDr Alka Gupta

Lala Lajpat Rai Memorial Medical College Meerut

dralkag@gmail.com09412201639

Outcome results

None listed

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