EndophthalmitisPhase 4NCT03363295
Evaluation of Macular Changes After Intracameral Moxifloxacin for Prevention of Endophthalmitis
A Phase 4 study testing Moxifloxacin Injection in people with Endophthalmitis and Macula Edema, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
The objective of this study is to evaluate the macular and choroidal thickness of patients submitted to intracameral moxifloxacin during the phacoemulsification surgery for endophthalmitis prophylaxis. The investigators propose a randomized clinical trial double-blind. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endophthalmitis, Macula Edema, Cataract
- What is being tested?
- Moxifloxacin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2017to 30 Dec 2019
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patients that will be submitted to phacoemulsification surgery in the Hospital de Clinicas of State University of Campinas (BRAZIL)
- Patients over 18 years old
- Patients who are able to perform SD-OCT
- Patients who sign the consent form
Who cannot join
- Diabetic patients
- Patients with any macular changes prior to the surgery (epiretinal membranes, age macular disease, macular edema...)
- Patients who had any complication during phacoemulsification surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation and Comparison of Macular and Choroidal Thickness After Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
The objective of this study is to evaluate the macular and choroidal thickness of patients submitted to intracameral moxifloxacin during the phacoemulsification surgery for endophthalmitis prophylaxis.
The investigators propose a randomized clinical trial double-blind. The patients will be divided into two groups: one will receive intracameral moxifloxacin injection during phacoemulsification surgery and the other won't.
Read more
Both Spectral Domain - Optical Coherence Tomography (SD-OCT) and Enhanced Depth Imaging - Optical Coherence Tomography (EDI-OCT) will be performed for each patient pre-operatively and on the 30th and 60th postoperative days.
After collecting, the data will be compared to evaluate if there was any difference in the macular thickness and choroidal thickness between the two groups.
Read the detailed description
Title:
Evaluation and Comparison of Macular and Choroidal Thickness after Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
Purpose:
The objective of this study is to evaluate if the using of intracameral moxifloxacin cause changes in macular and choroidal thickness.
Methods:
A randomized clinical trial will be conducted in the Hospital of Clinics at State University of Campinas (UNICAMP). The patients that will be submitted to phacoemulsification surgery will be divided into two groups. The first group will receive 0,03ml intracameral moxifloxacin after phacoemulsification surgery, while the second group won't receive any antibiotics intracamerally. Both groups will apply eyedrops as usual in the postoperative.
The investigators will evaluate those patients blindly. Each patient will be examined using Spectral Domain - Optical Coherence Tomography (SD-OCT) and Enhanced Depth Imaging - Optical Coherence Tomography (EDI-OCT), in the pre-operative, at the 30th postoperative and at the 60th postoperative. The data will be collected regarding macular central thickness and choroidal thickness.
The exclusion criteria will be:
- Patients who had any macular changes prior to the surgery (including epiretinal membrane, macular edema, drusen or any other)
- diabetic patients
- patients who had any complications during the cataract surgery
- patients who refuse to participate in the trial, or refuse to sign the consent form
After collecting data, the two groups will be compared regarding changes in macular thickness and choroidal thickness from the pre-operative, the 30th and the 60th postoperative.
The investigators expect that there will be no statistical difference between groups
- Conditions
- Endophthalmitis, Macula Edema, Cataract
- Being tested
- Moxifloxacin Injection
- Keywords
- endophthalmitis
- Medical subject headings
- Endophthalmitis, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin InjectionDrug
One group will receive moxifloxacin injection (0,03ml) in the anterior chamber by the end of phacoemulsification surgery
| Study group | Role | What they receive |
|---|---|---|
| Intracameral moxifloxacin | Experimental | Injection of 0,03ml of moxifloxacin in the anterior chamber following phacoemulsification surgery Receives: Drug: Moxifloxacin Injection |
| No - Intracameral moxifloxacin | No intervention | This group won't receive any prophylaxis after phacoemulsification surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Macular Thickness
Comparison of change in macular thickness using Spectral Domain - Optical Coherence Tomography
Measured: Change from baseline, 30th day postoperative and 60th day postoperative
Secondary outcomes (1)
Change of Choroidal Thickness
Comparison of change in macular thickness using Enhanced Depth Imaging - Optical Coherence Tomography
Measured: Change from baseline, 30th day postoperative and 60th day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Jul 2017
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndophthalmitisStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Pessoa Cavalcanti Lira, Universidade Federal de Pernambuco
- Investigators
- Mathias V Mélega, MD, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363295
- Sponsor's protocol ID
- 002
- Status last verified
- Nov 2022
- First submitted
- 25 Nov 2017
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferreira BG, Cardoso da Silva I, Melega MV, Nascimento MA, Cavalcanti Lira RP, Leite Arieta CE, Alves M. Macular and choroidal thickness after intracameral moxifloxacin for prevention of postcataract endophthalmitis. J Cataract Refract Surg. 2021 Jan 1;47(1):40-45. doi: 10.1097/j.jcrs.0000000000000365.
PubMed 32818353
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Comparison of Macular and Choroidal Thickness After Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
- ClinicalTrials.gov ID
- NCT03363295
- Acronym / sponsor ID
- 002
- Conditions
- Endophthalmitis, Macula Edema, Cataract
- Keywords
- endophthalmitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 6 Dec 2017 (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.
The objective of this study is to evaluate the macular and choroidal thickness of patients submitted to intracameral moxifloxacin during the phacoemulsification surgery for endophthalmitis prophylaxis.
The investigators propose a randomized clinical trial double-blind. The patients will be divided into two groups: one will receive intracameral moxifloxacin injection during phacoemulsification surgery and the other won't.
Both Spectral Domain - Optical Coherence Tomography (SD-OCT) and Enhanced Depth Imaging - Optical Coherence Tomography (EDI-OCT) will be performed for each patient pre-operatively and on the 30th and 60th postoperative days.
After collecting, the data will be compared to evaluate if there was any difference in the macular thickness and choroidal thickness between the two groups.
Detailed description
Title:
Evaluation and Comparison of Macular and Choroidal Thickness after Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
Purpose:
The objective of this study is to evaluate if the using of intracameral moxifloxacin cause changes in macular and choroidal thickness.
Methods:
A randomized clinical trial will be conducted in the Hospital of Clinics at State University of Campinas (UNICAMP). The patients that will be submitted to phacoemulsification surgery will be divided into two groups. The first group will receive 0,03ml intracameral moxifloxacin after phacoemulsification surgery, while the second group won't receive any antibiotics intracamerally. Both groups will apply eyedrops as usual in the postoperative.
The investigators will evaluate those patients blindly. Each patient will be examined using Spectral Domain - Optical Coherence Tomography (SD-OCT) and Enhanced Depth Imaging - Optical Coherence Tomography (EDI-OCT), in the pre-operative, at the 30th postoperative and at the 60th postoperative. The data will be collected regarding macular central thickness and choroidal thickness.
The exclusion criteria will be:
- Patients who had any macular changes prior to the surgery (including epiretinal membrane, macular edema, drusen or any other)
- diabetic patients
- patients who had any complications during the cataract surgery
- patients who refuse to participate in the trial, or refuse to sign the consent form
After collecting data, the two groups will be compared regarding changes in macular thickness and choroidal thickness from the pre-operative, the 30th and the 60th postoperative.
The investigators expect that there will be no statistical difference between groups
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracameral moxifloxacin | Experimental | Drug: Moxifloxacin InjectionInjection of 0,03ml of moxifloxacin in the anterior chamber following phacoemulsification surgery |
| No - Intracameral moxifloxacin | No intervention | –This group won't receive any prophylaxis after phacoemulsification surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any patients that will be submitted to phacoemulsification surgery in the Hospital de Clinicas of State University of Campinas (BRAZIL)
- Patients over 18 years old
- Patients who are able to perform SD-OCT
- Patients who sign the consent form
Key exclusion criteria (3 listed)
- Diabetic patients
- Patients with any macular changes prior to the surgery (epiretinal membranes, age macular disease, macular edema...)
- Patients who had any complication during phacoemulsification 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 |
|---|---|---|
| Moxifloxacin InjectionOne group will receive moxifloxacin injection (0,03ml) in the anterior chamber by the end of phacoemulsification surgery | Drug | Intracameral moxifloxacin |
Primary outcome
Change of Macular Thickness
Time frame: Change from baseline, 30th day postoperative and 60th day postoperative
Comparison of change in macular thickness using Spectral Domain - Optical Coherence Tomography
1 secondary outcome
Change of Choroidal Thickness
Time frame: Change from baseline, 30th day postoperative and 60th day postoperative
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 3 Nov 2022.
- Derived from this study: PubMed 32818353Ferreira BG, Cardoso da Silva I, Melega MV, Nascimento MA, Cavalcanti Lira RP, Leite Arieta CE, Alves M. Macular and choroidal thickness after intracameral moxifloxacin for prevention of postcataract endophthalmitis. J Cataract Refract Surg. 2021 Jan 1;47(1):40-45. doi: 10.1097/j.jcrs.0000000000000365.
- 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. This study is not recruiting at the moment.
Mathias V Mélega, MD principal investigator
University of Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Moxifloxacin Injection in people with Endophthalmitis and Macula Edema, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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 4 inclusion and 3 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 3 Nov 2022. 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 Brazil. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change of Macular Thickness (time frame: Change from baseline, 30th day postoperative and 60th day postoperative). 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 NCT03363295, which also lists 1 linked publication.
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 3 Nov 2022.