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Completed

NCT Number: NCT07605273

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Islamabad, Punjab Province, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Central corneal thickness

    Time frame: 6 days

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

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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