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

NCT07605273 | Completed

• 1 other identifier: Dr-Anum-Islamabad
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Corneal Edema

Outcome Measures

Primary Outcomes (1)

• Central corneal thickness

  Post-treatment central corneal thickness in micrometer was compared between the two groups.

  6 days

Study Arms (2)

Group-A

EXPERIMENTAL

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

Group-B

EXPERIMENTAL

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

Interventions

5% Hypertonic Saline DRUG

Patients received 5% hypertonic saline 2 hourly for the first 24 hours and then four times daily for the next 6 days.

Group-A

3% Hypertonic Saline DRUG

Patients received 3% hypertonic saline 2 hourly for the first 24 hours and then four times daily for the next 6 days.

Group-B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Pakistan Air Force (PAF) hospital/Fazaia Post Graduate Medical Institute

Islamabad, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Corneal Edema

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Anum Amin

  Pakistan Air Force (PAF) hospital/Fazaia Post Graduate Medical Institute, Islamabad

  PRINCIPAL INVESTIGATOR

• Muhammad Azam, FCPS

  Pakistan Air Force (PAF) hospital/Fazaia Post Graduate Medical Institute, Islamabad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start: June 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)