Corneal EdemaNCT07605273
Comparison of 5% Hypertonic Saline Versus 3% Hypertonic Saline in Resolution of Post-operative Corneal Edema.
A study testing 5% Hypertonic Saline and 3% Hypertonic Saline in people with Corneal Edema, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Corneal Edema
- What is being tested?
- 5% Hypertonic Saline and 3% Hypertonic Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Air Force (PAF) hospital/Fazaia Post Graduate Medical Institute
Islamabad, Punjab Province, 44000
About this study
Official 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.
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.
Read the 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.
- Conditions
- Corneal Edema
- Being tested
- 5% Hypertonic Saline, 3% Hypertonic Saline
- Medical subject headings
- Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% Hypertonic SalineDrug
Patients received 5% hypertonic saline 2 hourly for the first 24 hours and then four times daily for the next 6 days.
3% Hypertonic SalineDrug
Patients received 3% hypertonic saline 2 hourly for the first 24 hours and then four times daily for the next 6 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 3% Hypertonic Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central corneal thickness
Post-treatment central corneal thickness in micrometer was compared between the two groups.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jun 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Anum Amin, Principal investigator, Pakistan Air Force (PAF) hospital/Fazaia Post Graduate Medical Institute, IslamabadMuhammad Azam, FCPS, Study director, Pakistan Air Force (PAF) hospital/Fazaia Post Graduate Medical Institute, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605273
- Sponsor's protocol ID
- Dr-Anum-Islamabad
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07605273
- Acronym / sponsor ID
- Dr-Anum-Islamabad
- Conditions
- Corneal Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-A | Experimental | Drug: 5% Hypertonic SalinePatients received 5% hypertonic saline 2 hourly for the first 24 hours and then four times daily for the next 6 days. |
| Group-B | Experimental | Drug: 3% Hypertonic SalinePatients received 3% hypertonic saline 2 hourly for the first 24 hours and then four times daily for the next 6 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% Hypertonic SalinePatients received 5% hypertonic saline 2 hourly for the first 24 hours and then four times daily for the next 6 days. | Drug | Group-A |
| 3% Hypertonic SalinePatients received 3% hypertonic saline 2 hourly for the first 24 hours and then four times daily for the next 6 days. | Drug | Group-B |
Primary outcome
Central corneal thickness
Time frame: 6 days
Post-treatment central corneal thickness in micrometer was compared between the two groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
Related trials for Corneal Edema
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
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Active, not recruitingPhase 3
AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Corneal Endothelial Dysfunction
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The Belgian Endothelial Surgical Transplant of the Cornea
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Enrolling by invitationObservational study
The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Cataract
Recruiting
Plasma Rich in Growth Factors in Corneal Endothelial Transplantation
Fuchs' Endothelial Dystrophy, Corneal Edema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anum Amin principal investigator
Pakistan Air Force (PAF) hospital/Fazaia Post Graduate Medical Institute, Islamabad
Muhammad Azam, FCPS study director
Pakistan Air Force (PAF) hospital/Fazaia Post Graduate Medical Institute, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5% Hypertonic Saline and 3% Hypertonic Saline in people with Corneal Edema, run by Muhammad Aamir Latif at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central corneal thickness (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.