CataractNCT07850414
Intracameral Levofloxacin Versus Moxifloxacin After Cataract Surgery
A study testing Levofloxacin and Moxifloxacin in people with Cataract and Postoperative Endophthalmitis, run by Assiut University.
Trial summary
This randomized study aims to compare the safety and efficacy of intracameral levofloxacin versus intracameral moxifloxacin administered at the end of phacoemulsification cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Postoperative Endophthalmitis
- What is being tested?
- Levofloxacin and Moxifloxacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2026to 25 Feb 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Senile cataract scheduled for elective cataract surgery
- Undergoing standard phacoemulsification with foldable posterior chamber IOL implantation
- Healthy corneal endothelium with normal cell count on specular microscopy
- Written informed consent
- Willing and able to attend scheduled postoperative follow-up visits
Who cannot join
- - Active ocular infection or inflammation
- Complicated or traumatic cataract requiring non-standard surgical approach
- Known hypersensitivity to levofloxacin or moxifloxacin
- Unable or unwilling to comply with the postoperative follow-up schedule
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
Official title: Comparative Analysis of the Safety and Efficacy of Intracameral Injection of Levofloxacin and Moxifloxacin at the End of Cataract Surgery
This randomized study aims to compare the safety and efficacy of intracameral levofloxacin versus intracameral moxifloxacin administered at the end of phacoemulsification cataract surgery.
Read the detailed description
Postoperative endophthalmitis is a serious complication of cataract surgery. Intracameral antibiotics are used to reduce this risk.
This study will randomly assign patients undergoing elective phacoemulsification to receive either intracameral levofloxacin, intracameral moxifloxacin, or no intracameral antibiotic (control). Patients will be followed for visual outcomes, anterior chamber inflammation, and corneal endothelial safety.
- Conditions
- Cataract, Postoperative Endophthalmitis
- Being tested
- Levofloxacin, Moxifloxacin
- Keywords
- Intracameral antibiotic, Cataract surgery, Levofloxacin, Moxifloxacin, Assiut
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
0.1 mL of preservative-free levofloxacin 0.5% injected into the anterior chamber at the end of phacoemulsification.
MoxifloxacinDrug
0.1 mL of preservative-free moxifloxacin 0.5% injected into the anterior chamber at the end of phacoemulsification.
| Study group | Role | What they receive |
|---|---|---|
| Intracameral Levofloxacin | Experimental | Patients will receive 0.1 mL of preservative-free levofloxacin 0.5% injected into the anterior chamber at the end of phacoemulsification. Receives: Drug: Levofloxacin |
| Intracameral Moxifloxacin | Active comparator | Patients will receive 0.1 mL of preservative-free moxifloxacin 0.5% injected into the anterior chamber at the end of phacoemulsification. Receives: Drug: Moxifloxacin |
| No Intracameral Antibiotic | No intervention | Patients will undergo standard phacoemulsification without any intracameral antibiotic injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative endophthalmitis
Proportion of eyes that develop culture-proven or clinically diagnosed postoperative endophthalmitis.
Measured: 1 month
Secondary outcomes (5)
Mean best-corrected visual acuity
Mean best-corrected visual acuity (BCVA) in logMAR
Measured: 1 month
Mean endothelial cell density
Mean corneal endothelial cell density (cells/mm²) measured by specular microscopy.
Measured: 1 month
Mean anterior chamber cell grade
Mean grade of anterior chamber cells according to Standardization of Uveitis Nomenclature (SUN) criteria.
Measured: 1 week
Incidence of postoperative corneal edema
Proportion of eyes with clinically significant postoperative corneal edema.
Measured: 1 week
Mean central corneal thickness
Mean central corneal thickness in micrometers.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start26 Sep 2026 (estimated)
- Primary completion26 Sep 2027 (estimated)
- Study completion25 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherly Shamoun, Assiut University
- Investigators
- Mohamed s Abdel rahman, prof, Study chair, Ophthalmology Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850414
- Sponsor's protocol ID
- IC-FQ-Cataract-2026
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Safety and Efficacy of Intracameral Injection of Levofloxacin and Moxifloxacin at the End of Cataract Surgery
- ClinicalTrials.gov ID
- NCT07850414
- Acronym / sponsor ID
- IC-FQ-Cataract-2026
- Conditions
- Cataract, Postoperative Endophthalmitis
- Keywords
- Intracameral antibiotic, Cataract surgery, Levofloxacin, Moxifloxacin, Assiut
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Sep 2026 (estimated)
- Primary completion
- 26 Sep 2027 (estimated)
- Study completion
- 25 Feb 2028 (estimated)
- First posted
- 30 Sep 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.
This randomized study aims to compare the safety and efficacy of intracameral levofloxacin versus intracameral moxifloxacin administered at the end of phacoemulsification cataract surgery.
Detailed description
Postoperative endophthalmitis is a serious complication of cataract surgery. Intracameral antibiotics are used to reduce this risk.
This study will randomly assign patients undergoing elective phacoemulsification to receive either intracameral levofloxacin, intracameral moxifloxacin, or no intracameral antibiotic (control). Patients will be followed for visual outcomes, anterior chamber inflammation, and corneal endothelial safety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intracameral Levofloxacin | Experimental | Drug: LevofloxacinPatients will receive 0.1 mL of preservative-free levofloxacin 0.5% injected into the anterior chamber at the end of phacoemulsification. |
| Intracameral Moxifloxacin | Active comparator | Drug: MoxifloxacinPatients will receive 0.1 mL of preservative-free moxifloxacin 0.5% injected into the anterior chamber at the end of phacoemulsification. |
| No Intracameral Antibiotic | No intervention | –Patients will undergo standard phacoemulsification without any intracameral antibiotic injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - Senile cataract scheduled for elective cataract surgery
- Undergoing standard phacoemulsification with foldable posterior chamber IOL implantation
- Healthy corneal endothelium with normal cell count on specular microscopy
- Written informed consent
- Willing and able to attend scheduled postoperative follow-up visits
Key exclusion criteria (4 listed)
- - Active ocular infection or inflammation
- Complicated or traumatic cataract requiring non-standard surgical approach
- Known hypersensitivity to levofloxacin or moxifloxacin
- Unable or unwilling to comply with the postoperative follow-up schedule
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 |
|---|---|---|
| Levofloxacin0.1 mL of preservative-free levofloxacin 0.5% injected into the anterior chamber at the end of phacoemulsification. | Drug | Intracameral Levofloxacin |
| Moxifloxacin0.1 mL of preservative-free moxifloxacin 0.5% injected into the anterior chamber at the end of phacoemulsification. | Drug | Intracameral Moxifloxacin |
Primary outcome
Incidence of postoperative endophthalmitis
Time frame: 1 month
Proportion of eyes that develop culture-proven or clinically diagnosed postoperative endophthalmitis.
5 secondary outcomes
Mean best-corrected visual acuity
Time frame: 1 month
Mean endothelial cell density
Time frame: 1 month
Mean anterior chamber cell grade
Time frame: 1 week
Incidence of postoperative corneal edema
Time frame: 1 week
Mean central corneal thickness
Time frame: 1 month
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 30 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Mohamed s Abdel rahman, prof study chair
Ophthalmology Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
A study testing Levofloxacin and Moxifloxacin in people with Cataract and Postoperative Endophthalmitis, run by Assiut 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 4 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 30 Sep 2026. 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 Sherly S Sobhy, Resident (01281224292, Sherly.21413@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative endophthalmitis (time frame: 1 month). 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 30 Sep 2026.