Comparison of 5% Hypertonic Saline Versus 3% Hypertonic Saline in Resolution of Post-operative Corneal Edema.

May 18, 2026 updated by: Muhammad Aamir Latif

Effectiveness of 5% Hypertonic Saline Versus 3% Hypertonic Saline in Resolution of Corneal Edema in Post-operative Phacoemulsification Patients at the Department of Ophthalmology, Pakistan Air Force Hospital Islamabad.

There is a lack of data to determine the comparative advantages of 5% hypertonic saline and 3% hypertonic saline over the other. Hence, the current study was planned to determine their comparative effectiveness by comparing the change in means of central corneal thickness in the groups receiving 3% hypertonic saline and 5% hypertonic saline eyedrops developing post-phacoemulsification corneal edema.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although corneal edema and the associated visual impairment after cataract surgery are temporary, it is still a reason for discomfort for the patient. It is therefore absolutely necessary that the patient be counselled regarding the risk of developing corneal edema after phacoemulsification. Several international studies have demonstrated the effectiveness of 5% hypertonic saline in improving visual acuity and reducing corneal thickness through clinical and pachymetric assessments. However, similar research has yet to be conducted in the Pakistani population. The findings of this study would add to the existing literature and also help clinicians to opt for the better choice of care in achieving patients' good outcomes.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Islamabad, Punjab Province, Pakistan, 44000
        • Pakistan Air Force (PAF) hospital/Fazaia Post Graduate Medical Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of any gender
  • Aged 18 years and above
  • Patients who went through phacoemulsification with cumulative dissipated energy (CDE) between 25 and 40 units and developed corneal edema as a postoperative complication.

Exclusion Criteria:

  • Patients predisposed to corneal edema due to corneal dystrophies, including Fuch's endothelial dystrophy, posterior polymorphous corneal dystrophy, or congenital hereditary endothelial dystrophy.
  • With pre-existing inflammatory conditions like primary endothelitis or stromal viral keratitis
  • Any prior trauma to the eye affecting study outcomes.
  • Allergic to normal saline.
  • On oral or topical steroids for the last month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group-A
Patients received 5% hypertonic saline 2 hourly for the first 24 hours and then four times daily for the next 6 days.
Drug: 5% Hypertonic Saline
Patients received 5% hypertonic saline 2 hourly for the first 24 hours and then four times daily for the next 6 days.
Experimental: Group-B
Patients received 3% hypertonic saline 2 hourly for the first 24 hours and then four times daily for the next 6 days.
Drug: 3% Hypertonic Saline
Patients received 3% hypertonic saline 2 hourly for the first 24 hours and then four times daily for the next 6 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central corneal thickness
Time Frame: 6 days
Post-treatment central corneal thickness in micrometer was compared between the two groups.
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muhammad Aamir Latif

Investigators

  • Principal Investigator: Anum Amin, Pakistan Air Force (PAF) hospital/Fazaia Post Graduate Medical Institute, Islamabad
  • Study Director: Muhammad Azam, FCPS, Pakistan Air Force (PAF) hospital/Fazaia Post Graduate Medical Institute, Islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dr-Anum-Islamabad

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be shared on a reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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