Endophthalmitis PostoperativePhase 4NCT03634852
A Two Chemoprophylaxis Approaches After Phacoemulsification Surgery
A Phase 4 study testing Moxifloxacin hydrochloride 0.5% eye drops, Dexamethasone 0.1% eye drops and Intracameral Moxifloxacin 0.1% in people with Endophthalmitis Postoperative, run by Suzan A Rattan.
Trial summary
Post cataract surgery bacterial endophthalmitis is a rare but the most devastating complication with a poor visual outcome. The preferred pattern of chemoprophylaxis varied world widely. The use of preoperative povidone iodine is universal. Read more about this study
- Who is it for?
- Ages 38 to 70 years
- Conditions the study is for
- Endophthalmitis Postoperative
- What is being tested?
- Moxifloxacin hydrochloride 0.5% eye drops, Dexamethasone 0.1% eye drops and Intracameral Moxifloxacin 0.1%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 1 Feb 2018
- 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 38 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- For group 2; any patient used a topical antibiotic, nonsteroidal anti-inflammatory drug (NSAID) or corticosteroid up to 1 week before the planned day of surgery,
- any patient with a history of glaucoma or steroid responsiveness
- any patient with significant maculopathy were excluded from the current comparison.
About this study
Official title: A Two Different Chemoprophylaxis Approaches After Phacoemulsification Surgery in One Thousand Patients in Iraq :a Clinical Trial
Post cataract surgery bacterial endophthalmitis is a rare but the most devastating complication with a poor visual outcome.
The preferred pattern of chemoprophylaxis varied world widely. The use of preoperative povidone iodine is universal. Most European surgeons prefer the use of Intracameral (IC) antibiotics whereas topical fluoroquinolone that prescribed perioperatively is the most common pattern in the United state(US). The current study aimed to evaluate the effectivity and safety of a combination of diluted IC Moxifloxacin and subconjunctival (SC) Triamcinolone acetonide as prophylaxis of bacterial endophthalmitis and postoperative inflammation in five hundred phacoemulsification surgeries and compare its results with the same number of patients treated by topical Moxifloxacin hydrochloride and Dexamethasone eye drops when given four times a day for 1month postoperatively.
Read the detailed description
Study design and populations:
The current clinical trial included a total 1000 patients with visually significant cataract scheduled to have phacoemulsification surgery at an Eye specialty private hospital in Baghdad /Iraq during 18 months period from 1st of October 2016 to 1st of February 2018 by two surgeons.
The current two methods of prophylaxis of postoperative endophthalmitis and inflammation were discussed with the patients and informed consent was obtained about the treatment and the enrollment in the current study.
Two methods of prophylaxis of postoperative bacterial endophthalmitis and inflammation were planned to use. For 500 patients (group 1) topical moxifloxacin hydrochloride 0.5% (Vigamox,Alcon) and dexamethasone 0.1%(Maxidex, Alcon) eye drops prescribed four times a day for 1-month postoperatively ,while for the remaining 500 patients (group 2), intracameral (IC) diluted moxifloxacin 0.1% and subconjunctival triamcinolone acetonide 4 mg/0.4 cc is the combination that planned to used for prophylaxis.
Preoperative evaluations:
The two surgeons follow the same protocol for the preoperative evaluation including slit lamp, Goldmann applanation tonometry(AT900, Haag-Streit Diagnostics, Switzerland), dilated fundus examination and macular optical coherence tomography (OCT)(Optovue, RTVue-100, Fremont, CA).
Follow- up visits were on the first postoperative day, 1week, 1 month, and 3months postoperatively.
The mean age of patients in group 1 was 59.4 years ± 9.04, 300 were female and 200 were male, 160 with type 2 diabetes mellitus without retinopathy and the preoperative intraocular pressure (IOP) range were from 10 to 25 mmHg with mean 14.49 mmHg ± 3.11.
Group 2 patients had a mean age of 59.7 ±8.84, 320 were female and 180 were male, 140 with good controlled diabetes and preoperative IOP mean was 14.47 mmHg ±3.10 range was from 9.5-20.6 mmHg.
statistical analysis: Minitab 16 software used for data statistical analysis, data were expressed in mean ± standard deviation (SD), for each group the preoperative baseline versus the corresponding postoperative data were compared by paired-sample t-test, while for the comparison of the 2 independent groups we used two-sample t-test and the results considered statistically significant if P value < 0.05.
- Conditions
- Endophthalmitis Postoperative
- Being tested
- Moxifloxacin hydrochloride 0.5% eye drops, Dexamethasone 0.1% eye drops, Intracameral Moxifloxacin 0.1%, Subconjunctival Triamcinolone acetonide 4 mg /0.4 ml
- Keywords
- IC Moxifloxacin hydrochloride, SC triamcinolone acetonide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin hydrochloride 0.5% eye dropsDrug
Also called Vigamox eye drops
were prescribed four times a day for 1-month postoperatively
Dexamethasone 0.1% eye dropsDrug
Also called Maxidex eye drops
were prescribed four times a day for 1-month postoperatively
Intracameral Moxifloxacin 0.1%Drug
Also called Auromox
Auromox (0.5%): is a sterile clear yellow pale colored preservative free isotonic ophthalmic solution with pH 6.0 to 7.5 and osmolarity 620 -320 milliosmol ( mOsm).The sterile Auromox vial contains 1cc Moxifloxacin hydrochloride 5.45 mg equivalent to 5mg of Moxifloxacin. This product is manufactured by Aurolab an Indian pharmaceutical company. Auromox is available in many countries including Iraq.
Each vial enough for 15 different patients by using a sterile needle and 5cc syringe. By the sterile hand's, the surgeon draws the whole 1cc of Moxifloxacin 0.5% and diluted with 4 cc of balanced salt solution (BSS) to get 5 mg in 5 cc (0.1%) then draw 0.2 cc for each patient.
Subconjunctival Triamcinolone acetonide 4 mg /0.4 mlDrug
Also called Aurocort
Aurocort is a preservative-free Triamcinolone acetonide (40 mg /1cc), with along acting depot preparation of triamcinolone in 1cc vial also the product of Aurolab company and commercially available in our country.
The whole 1cc had been drawn and diluted with 3cc of BSS and SC injection of 4 mg in 0.4 cc of Triamcinolone was given (as a final step in the surgery) 6mm from the limbus usually an inferotemporal site that is easily accessible and the plaque that formed will be not visible within palpebral fissure
| Study group | Role | What they receive |
|---|---|---|
| Topical | Active comparator | Moxifloxacin hydrochloride 0.5% eye drops and dexamethasone 0.1% eye drops were prescribed four times a day for 1 month postoperatively. Receives: Drug: Moxifloxacin hydrochloride 0.5% eye drops; Drug: Dexamethasone 0.1% eye drops |
| Intracameral - Subconjunctival | Active comparator | Intracameral Moxifloxacin 0.1% with Subconjunctival Triamcinolone acetonide 4 mg /0.4 ml had been administered at the conclusion of the surgery Receives: Drug: Intracameral Moxifloxacin 0.1%; Drug: Subconjunctival Triamcinolone acetonide 4 mg /0.4 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Bacterial endophthalmitis in 1000 phacoemulsification surgeries
All patients assessed by slit lamp examination for possibility of early or late onset bacterial endophthalmitis after phacoemulsification surgery.
Measured: The duration of follow up for each patient was a 3 months postoperatively.
Secondary outcomes (1)
Intraocular pressure(IOP) was measured on 1week,1month,and 3 months visits by Goldmann applanation tonometry .
For all patients IOP was measured during the last 3 visits to exclude the possibility of significant IOP elevation (> 10 mmHg from the base line) after phacoemulsification surgery with the use of 2 different methods of chemoprophylaxis and to show which of them has the more possibility to increase IOP
Measured: The duration of follow up for each patient was a 3 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Oct 2016
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endophthalmitis PostoperativeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzan A Rattan
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Kindy College of Medicine
- Responsible party
- Sponsor-investigator, Suzan A Rattan, Al-Kindy College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634852
- Sponsor's protocol ID
- 2 Al-KindyCM
- Status last verified
- Aug 2018
- First submitted
- 31 Jul 2018
- Last updated
- 3 May 2023
- 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Different Chemoprophylaxis Approaches After Phacoemulsification Surgery in One Thousand Patients in Iraq :a Clinical Trial
- ClinicalTrials.gov ID
- NCT03634852
- Acronym / sponsor ID
- 2 Al-KindyCM
- Conditions
- Endophthalmitis Postoperative
- Keywords
- IC Moxifloxacin hydrochloride, SC triamcinolone acetonide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Suzan A RattanUniversity, hospital or other
- Collaborators
- Al-Kindy College of Medicine
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 17 Aug 2018 (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.
Post cataract surgery bacterial endophthalmitis is a rare but the most devastating complication with a poor visual outcome.
The preferred pattern of chemoprophylaxis varied world widely. The use of preoperative povidone iodine is universal. Most European surgeons prefer the use of Intracameral (IC) antibiotics whereas topical fluoroquinolone that prescribed perioperatively is the most common pattern in the United state(US). The current study aimed to evaluate the effectivity and safety of a combination of diluted IC Moxifloxacin and subconjunctival (SC) Triamcinolone acetonide as prophylaxis of bacterial endophthalmitis and postoperative inflammation in five hundred phacoemulsification surgeries and compare its results with the same number of patients treated by topical Moxifloxacin hydrochloride and Dexamethasone eye drops when given four times a day for 1month postoperatively.
Detailed description
Study design and populations:
The current clinical trial included a total 1000 patients with visually significant cataract scheduled to have phacoemulsification surgery at an Eye specialty private hospital in Baghdad /Iraq during 18 months period from 1st of October 2016 to 1st of February 2018 by two surgeons.
The current two methods of prophylaxis of postoperative endophthalmitis and inflammation were discussed with the patients and informed consent was obtained about the treatment and the enrollment in the current study.
Two methods of prophylaxis of postoperative bacterial endophthalmitis and inflammation were planned to use. For 500 patients (group 1) topical moxifloxacin hydrochloride 0.5% (Vigamox,Alcon) and dexamethasone 0.1%(Maxidex, Alcon) eye drops prescribed four times a day for 1-month postoperatively ,while for the remaining 500 patients (group 2), intracameral (IC) diluted moxifloxacin 0.1% and subconjunctival triamcinolone acetonide 4 mg/0.4 cc is the combination that planned to used for prophylaxis.
Preoperative evaluations:
The two surgeons follow the same protocol for the preoperative evaluation including slit lamp, Goldmann applanation tonometry(AT900, Haag-Streit Diagnostics, Switzerland), dilated fundus examination and macular optical coherence tomography (OCT)(Optovue, RTVue-100, Fremont, CA).
Follow- up visits were on the first postoperative day, 1week, 1 month, and 3months postoperatively.
The mean age of patients in group 1 was 59.4 years ± 9.04, 300 were female and 200 were male, 160 with type 2 diabetes mellitus without retinopathy and the preoperative intraocular pressure (IOP) range were from 10 to 25 mmHg with mean 14.49 mmHg ± 3.11.
Group 2 patients had a mean age of 59.7 ±8.84, 320 were female and 180 were male, 140 with good controlled diabetes and preoperative IOP mean was 14.47 mmHg ±3.10 range was from 9.5-20.6 mmHg.
statistical analysis: Minitab 16 software used for data statistical analysis, data were expressed in mean ± standard deviation (SD), for each group the preoperative baseline versus the corresponding postoperative data were compared by paired-sample t-test, while for the comparison of the 2 independent groups we used two-sample t-test and the results considered statistically significant if P value < 0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical | Active comparator | Drug: Moxifloxacin hydrochloride 0.5% eye drops, Drug: Dexamethasone 0.1% eye dropsMoxifloxacin hydrochloride 0.5% eye drops and dexamethasone 0.1% eye drops were prescribed four times a day for 1 month postoperatively. |
| Intracameral - Subconjunctival | Active comparator | Drug: Intracameral Moxifloxacin 0.1%, Drug: Subconjunctival Triamcinolone acetonide 4 mg /0.4 mlIntracameral Moxifloxacin 0.1% with Subconjunctival Triamcinolone acetonide 4 mg /0.4 ml had been administered at the conclusion of the surgery |
Who may qualify
- Ages
- 38 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- For group 2; any patient used a topical antibiotic, nonsteroidal anti-inflammatory drug (NSAID) or corticosteroid up to 1 week before the planned day of surgery,
- any patient with a history of glaucoma or steroid responsiveness
- any patient with significant maculopathy were excluded from the current comparison.
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 hydrochloride 0.5% eye dropsAlso: Vigamox eye dropswere prescribed four times a day for 1-month postoperatively | Drug | Topical |
| Dexamethasone 0.1% eye dropsAlso: Maxidex eye dropswere prescribed four times a day for 1-month postoperatively | Drug | Topical |
| Intracameral Moxifloxacin 0.1%Also: AuromoxAuromox (0.5%): is a sterile clear yellow pale colored preservative free isotonic ophthalmic solution with pH 6.0 to 7.5 and osmolarity 620 -320 milliosmol ( mOsm).The sterile Auromox vial contains 1cc Moxifloxacin hydrochloride 5.45 mg equivalent to 5mg of Moxifloxacin. This product is manufactured by Aurolab an Indian pharmaceutical company. Auromox is available in many countries including Iraq. Each vial enough for 15 different patients by using a sterile needle and 5cc syringe. By the sterile hand's, the surgeon draws the whole 1cc of Moxifloxacin 0.5% and diluted with 4 cc of balanced salt solution (BSS) to get 5 mg in 5 cc (0.1%) then draw 0.2 cc for each patient. | Drug | Intracameral - Subconjunctival |
| Subconjunctival Triamcinolone acetonide 4 mg /0.4 mlAlso: AurocortAurocort is a preservative-free Triamcinolone acetonide (40 mg /1cc), with along acting depot preparation of triamcinolone in 1cc vial also the product of Aurolab company and commercially available in our country. The whole 1cc had been drawn and diluted with 3cc of BSS and SC injection of 4 mg in 0.4 cc of Triamcinolone was given (as a final step in the surgery) 6mm from the limbus usually an inferotemporal site that is easily accessible and the plaque that formed will be not visible within palpebral fissure | Drug | Intracameral - Subconjunctival |
Primary outcome
Incidence of Bacterial endophthalmitis in 1000 phacoemulsification surgeries
Time frame: The duration of follow up for each patient was a 3 months postoperatively.
All patients assessed by slit lamp examination for possibility of early or late onset bacterial endophthalmitis after phacoemulsification surgery.
1 secondary outcome
Intraocular pressure(IOP) was measured on 1week,1month,and 3 months visits by Goldmann applanation tonometry .
Time frame: The duration of follow up for each patient was a 3 months postoperatively.
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 May 2023.
- Individual participant dataSharing planned: No
Related trials for Endophthalmitis Postoperative
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Intracameral Levofloxacin Versus Moxifloxacin After Cataract Surgery
Cataract, Postoperative Endophthalmitis
RecruitingObservational study
Vascular Changes Associated With Endophthalmitis.
Endophthalmitis
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Moxifloxacin hydrochloride 0.5% eye drops, Dexamethasone 0.1% eye drops and Intracameral Moxifloxacin 0.1% in people with Endophthalmitis Postoperative, run by Suzan A Rattan.
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 0 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 May 2023. 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.
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?
Incidence of Bacterial endophthalmitis in 1000 phacoemulsification surgeries (time frame: The duration of follow up for each patient was a 3 months postoperatively.). 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 3 May 2023.