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

Muhammad Aamir Latif

Status: Completed

Conditions: Corneal Edema

Treatments: Drug: 3% Hypertonic Saline; Drug: 5% Hypertonic Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07605273

Dr-Anum-Islamabad

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Group-A

Experimental group

Description:

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

Treatment:

Drug: 5% Hypertonic Saline

Group-B

Experimental group

Description:

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

Treatment:

Drug: 3% Hypertonic Saline