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Clinical Trials/CTRI/2025/03/083370
CTRI/2025/03/083370Not yet recruitingNot Applicable

A comparative study of surgically induced astigmatism (SIA) in temporal and on-axis clear corneal incision in patients undergoing phacoemulsification- Randomized controlled trial

Bhashitha Chowdary Koripalli1 site in 1 country120 target enrollmentStarted: April 5, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
corneal curvature, astigmatism, vision pre and postop

Study Overview

Brief Summary

SURGICALLY INDUCED ASTIGMATISM (SIA) IN TEMPORAL AND ON-AXIS CLEAR CORNEAL INCISION IN PATIENTS UNDERGOING PHACOEMULSIFICATION – RANDOMIZED CONTROLLED TRIAL

Primary objectives: To compare the Surgically Induced Astigmatism (SIA) between Temporal Clear Corneal Incision (TCCI) and On-Axis Clear Corneal Incision (OCCI) in patients undergoing phacoemulsification

Secondary objectives:

1.     To compare the coupling ratio between temporal clear corneal (TCCI) and On-Axis Clear Corneal Incision (OCCI) in patients undergoing phacoemulsification

2.     To compare the Visual outcome between temporal clear corneal (TCCI) and On-Axis Clear Corneal Incision (OCCI) in patients undergoing phacoemulsification

Description of study groups (for comparative/analytical studies only):

In this study, the participants will be divided into 2 groups

GROUP A – patients undergoing phacoemulsification with Temporal Clear Corneal Incision

GROUP B - On axis Clear corneal incision. Pre and post op keratometry values, astigmatism, coupling ratio, visual acuity will be compared between the two groups.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Age more than 18 years, patients undergoing phacoemulsification with corneal astigmatism less than 3.00 D.

Exclusion Criteria

  • Corneal sutures, any h/o ocular surgery, corneal opacity, any other ocular diseases which might decrease the visual potential after cataract surgery.

Outcomes

Primary Outcomes

corneal curvature, astigmatism, vision pre and postop

Time Frame: Baseline, day 1, 1 week, 3 weeks, 9 weeks

Secondary Outcomes

  • corneal curvature and vision pre and postop(preop and 3months followup)

Investigators

Sponsor
Bhashitha Chowdary Koripalli
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Bhashitha Chowdary Koripalli

Pondicherry Institute of Medical Sciences

Study Sites (1)

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