CataractEarly Phase 1NCT06710977
To Compare the Safety and Efficacy of Intracameral Levofloxacin and Intracameral Cefazolin in Reducing Rates of Endophthalmitis Following Cataract Surgery.
A Early Phase 1 study testing Safety of intracameral levofloxacin in cataract surgery and Use of intracameral cefazolin in cataract surgery in people with Cataract, run by Tan Tock Seng Hospital at 2 sites in Singapore.
Trial summary
Patients with senile cataracts undergoing phacoemulsification were assigned to receive intracameral levofloxacin (0.1ml/0.5mg) or intracameral cefazolin (0.1ml/1mg). The primary endpoint was the occurrence of endophthalmitis during the 3 month follow-up period. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- Safety of intracameral levofloxacin in cataract surgery and Use of intracameral cefazolin in cataract surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 Jan 2022to 1 Sep 2024
- Phase
- Early Phase 1
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥50 to <80 years
- Undergoing cataract surgery under the care of one of three study investigators, all of whom were consultant level cataract surgeons
- Only those with senile cataracts, assessed using the Lens Opacities Classification System III scale (LOCS III) and without features of complex cataracts were included
Who cannot join
- <50 or >80 years old
- Prior ocular trauma, pregnant, previous history of refractive, corneal or intraocular surgery, cornea endothelial cell count <1500/sqmm², concomitant ocular disease, allergy to penicillin, fluoroquinolone or cephalosporin, and abnormal biometric measurements
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Tan Tock Seng Hospital
Singapore, 308433
Ang Mo Kio Specialist Center
Singapore, 560723
About this study
Official title: A Double-blind, Randomized Controlled Pilot Study Comparing the Safety and Efficacy of Intracameral Levofloxacin and Intracameral Cefazolin in Cataract Surgery
Patients with senile cataracts undergoing phacoemulsification were assigned to receive intracameral levofloxacin (0.1ml/0.5mg) or intracameral cefazolin (0.1ml/1mg). The primary endpoint was the occurrence of endophthalmitis during the 3 month follow-up period. Secondary endpoints included best-corrected visual acuity (BVCA), the presence of anterior chamber (AC) inflammation with grading of AC cells and presence of flare, along with intraocular pressure (IOP), corneal cell thickness (CCT), central foveal thickness (CFT) and cell density.
- Conditions
- Cataract
- Being tested
- Safety of intracameral levofloxacin in cataract surgery, Use of intracameral cefazolin in cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety of intracameral levofloxacin in cataract surgeryDrug
Intracameral levofloxacin (0.1ml/0.5mg)
Use of intracameral cefazolin in cataract surgeryDrug
Intracameral cefazolin (0.1ml/1mg)
| Study group | Role | What they receive |
|---|---|---|
| Safety of Intracameral levofloxacin in cataract surgery | Experimental | Eligible and recruited patients are randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery Receives: Drug: Safety of intracameral levofloxacin in cataract surgery; Drug: Use of intracameral cefazolin in cataract surgery |
| Use of intracameral cefazolin in cataract surgery | Active comparator | Eligible and recruited patients were randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery Receives: Drug: Safety of intracameral levofloxacin in cataract surgery; Drug: Use of intracameral cefazolin in cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment related adverse events to Intracameral Cefazolin versus Levofloxacin
Measured: From cataract surgery through to study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Jan 2022
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CataractStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710977
- Sponsor's protocol ID
- 2021/00844-SSR3
- Status last verified
- Oct 2024
- First submitted
- 20 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon publication, we will be providing contact details such that keen parties can approach us to get clarification or access to the data.
Publications
Cruz FM, Uy HS, Rubio CJ, Chan PS. Postoperative Safety Outcomes in Patients Undergoing Routine Phacoemulsification Cataract Surgery with Intraoperative Intracameral Injection of Preservative-Free Moxifloxacin versus Levofloxacin. Philippine Journal of Ophthalmology. 2022;47(1)
Espiritu CRG, Bolinao JG. Prophylactic intracameral levofloxacin in cataract surgery - an evaluation of safety. Clin Ophthalmol. 2017 Dec 12;11:2199-2204. doi: 10.2147/OPTH.S144625. eCollection 2017.
PubMed 29276375Koh YT, Yeo TK, Toh ZH, Wong JXH, Ngo WK, Fam HB, Pek DCK. A double-blind, randomized controlled pilot study comparing the safety of intracameral levofloxacin and intracameral cefazolin in patients undergoing cataract surgery. Sci Rep. 2025 Oct 2;15(1):34444. doi: 10.1038/s41598-025-17553-6.
PubMed 41038947
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized Controlled Pilot Study Comparing the Safety and Efficacy of Intracameral Levofloxacin and Intracameral Cefazolin in Cataract Surgery
- ClinicalTrials.gov ID
- NCT06710977
- Acronym / sponsor ID
- 2021/00844-SSR3
- Conditions
- Cataract
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 2 Dec 2024 (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 with senile cataracts undergoing phacoemulsification were assigned to receive intracameral levofloxacin (0.1ml/0.5mg) or intracameral cefazolin (0.1ml/1mg). The primary endpoint was the occurrence of endophthalmitis during the 3 month follow-up period. Secondary endpoints included best-corrected visual acuity (BVCA), the presence of anterior chamber (AC) inflammation with grading of AC cells and presence of flare, along with intraocular pressure (IOP), corneal cell thickness (CCT), central foveal thickness (CFT) and cell density.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safety of Intracameral levofloxacin in cataract surgery | Experimental | Drug: Safety of intracameral levofloxacin in cataract surgery, Drug: Use of intracameral cefazolin in cataract surgeryEligible and recruited patients are randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery |
| Use of intracameral cefazolin in cataract surgery | Active comparator | Drug: Safety of intracameral levofloxacin in cataract surgery, Drug: Use of intracameral cefazolin in cataract surgeryEligible and recruited patients were randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥50 to <80 years
- Undergoing cataract surgery under the care of one of three study investigators, all of whom were consultant level cataract surgeons
- Only those with senile cataracts, assessed using the Lens Opacities Classification System III scale (LOCS III) and without features of complex cataracts were included
Key exclusion criteria (2 listed)
- <50 or >80 years old
- Prior ocular trauma, pregnant, previous history of refractive, corneal or intraocular surgery, cornea endothelial cell count <1500/sqmm², concomitant ocular disease, allergy to penicillin, fluoroquinolone or cephalosporin, and abnormal biometric measurements
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 |
|---|---|---|
| Safety of intracameral levofloxacin in cataract surgeryIntracameral levofloxacin (0.1ml/0.5mg) | Drug | Safety of Intracameral levofloxacin in cataract surgery, Use of intracameral cefazolin in cataract surgery |
| Use of intracameral cefazolin in cataract surgeryIntracameral cefazolin (0.1ml/1mg) | Drug | Safety of Intracameral levofloxacin in cataract surgery, Use of intracameral cefazolin in cataract surgery |
Primary outcome
Number of Participants with Treatment related adverse events to Intracameral Cefazolin versus Levofloxacin
Time frame: From cataract surgery through to study completion, an average of 1 year
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 2 Dec 2024.
- BackgroundCruz FM, Uy HS, Rubio CJ, Chan PS. Postoperative Safety Outcomes in Patients Undergoing Routine Phacoemulsification Cataract Surgery with Intraoperative Intracameral Injection of Preservative-Free Moxifloxacin versus Levofloxacin. Philippine Journal of Ophthalmology. 2022;47(1)
- Background: PubMed 29276375Espiritu CRG, Bolinao JG. Prophylactic intracameral levofloxacin in cataract surgery - an evaluation of safety. Clin Ophthalmol. 2017 Dec 12;11:2199-2204. doi: 10.2147/OPTH.S144625. eCollection 2017.
- Derived from this study: PubMed 41038947Koh YT, Yeo TK, Toh ZH, Wong JXH, Ngo WK, Fam HB, Pek DCK. A double-blind, randomized controlled pilot study comparing the safety of intracameral levofloxacin and intracameral cefazolin in patients undergoing cataract surgery. Sci Rep. 2025 Oct 2;15(1):34444. doi: 10.1038/s41598-025-17553-6.
- Individual participant dataSharing planned: No. Upon publication, we will be providing contact details such that keen parties can approach us to get clarification or access to the data.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Safety of intracameral levofloxacin in cataract surgery and Use of intracameral cefazolin in cataract surgery in people with Cataract, run by Tan Tock Seng Hospital at 2 sites in Singapore.
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 2 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 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of Participants with Treatment related adverse events to Intracameral Cefazolin versus Levofloxacin (time frame: From cataract surgery through to study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06710977, which also lists 3 linked publications.
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 2 Dec 2024.