Corneal DiseasesNCT06904560
The Relation Between BSS Solution Temperature and Endothelial Cells and Post Phaco Discomfort
A study testing phacoemulsification in people with Corneal Diseases, run by Sohag University.
Trial summary
patients underwent phacoemulsification , balanced saline solution used during the operation will be at room temperature in one group and cool 2.7 c in the other group. the patients will be followed for 3 months after phacoemulsification regarding corneal endothelial cells and anterior segment inflammatory signs Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Corneal Diseases
- What is being tested?
- phacoemulsification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with cataract
- more than 40 years
- no glaucoma
- no retinal abnormalities
- no retinal abnormalities
Who cannot join
- patients with corneal diseases patients less than 40 patients with previous eye surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
patients underwent phacoemulsification , balanced saline solution used during the operation will be at room temperature in one group and cool 2.7 c in the other group. the patients will be followed for 3 months after phacoemulsification regarding corneal endothelial cells and anterior segment inflammatory signs
Read the detailed description
patients underwent phacoemulsification , balanced saline solution used during the operation will be at room temperature in one group and cool 2.7 c in the other group. the patients will be followed for 3 months after phacoemulsification regarding corneal endothelial cells and anterior segment inflammatory signs
- Conditions
- Corneal Diseases
- Being tested
- phacoemulsification
- Keywords
- cornea, cataract
- Medical subject headings
- Corneal Diseases, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsificationOther
one group with BSS at room temperature and the other group with cold BSS
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Other | patients underwent phacoemulsification , balanced saline solution at room temperature will be used for irrigation Receives: Other: phacoemulsification |
| group 2 | Experimental | patients underwent phacoemulsification , balanced saline solution with low (cold ) temperature will be used for irrigation Receives: Other: phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial cell count
Measured: 3 months
Secondary outcomes (1)
incidence of anterior segment inflammation
incidence of anterior segment inflammation including conjunctival hypremia or corneal edema
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DiseasesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Mahmoud,MD, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904560
- Sponsor's protocol ID
- sohag-med-25-1-5PD
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between BSS Solution Temperature and Endothelial Cells and Post Phaco Discomfort
- ClinicalTrials.gov ID
- NCT06904560
- Acronym / sponsor ID
- sohag-med-25-1-5PD
- Conditions
- Corneal Diseases
- Keywords
- cornea, cataract
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 1 Apr 2025 (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.
patients underwent phacoemulsification , balanced saline solution used during the operation will be at room temperature in one group and cool 2.7 c in the other group. the patients will be followed for 3 months after phacoemulsification regarding corneal endothelial cells and anterior segment inflammatory signs
Detailed description
patients underwent phacoemulsification , balanced saline solution used during the operation will be at room temperature in one group and cool 2.7 c in the other group. the patients will be followed for 3 months after phacoemulsification regarding corneal endothelial cells and anterior segment inflammatory signs
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Other | Other: phacoemulsificationpatients underwent phacoemulsification , balanced saline solution at room temperature will be used for irrigation |
| group 2 | Experimental | Other: phacoemulsificationpatients underwent phacoemulsification , balanced saline solution with low (cold ) temperature will be used for irrigation |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with cataract
- more than 40 years
- no glaucoma
- no retinal abnormalities
- no retinal abnormalities
Key exclusion criteria (1 listed)
- patients with corneal diseases patients less than 40 patients with previous eye surgery
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 |
|---|---|---|
| phacoemulsificationone group with BSS at room temperature and the other group with cold BSS | Other | group 1, group 2 |
Primary outcome
endothelial cell count
Time frame: 3 months
1 secondary outcome
incidence of anterior segment inflammation
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing phacoemulsification in people with Corneal Diseases, run by Sohag University.
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 5 inclusion and 1 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: opening soon, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hany Mahmoud (01024368111, drhanymahmoud@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endothelial cell count (time frame: 3 months). 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 1 Apr 2025.