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

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.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07605273

Enrollment

Registered

2026-05-22

Start date

2025-06-01

Completion date

2025-12-31

Last updated

2026-05-22

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

Conditions

Corneal Edema

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.

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.

Interventions

DRUG5% Hypertonic Saline

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

DRUG3% Hypertonic Saline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Pakistan

Contacts

PRINCIPAL_INVESTIGATORAnum Amin

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

STUDY_DIRECTORMuhammad Azam, FCPS