Endophthalmitis Following Cataract SurgeryNCT03958292
Conjunctival Flora Before Cataract Surgery: a Microbiological Evaluation
A study testing IODIM in people with Endophthalmitis Following Cataract Surgery, run by Ospedale Sacra Famiglia - Fatebenefratelli Erba at 6 sites in Italy.
Trial summary
The purpose of the present study is to elucidate the qualitative and quantitative variation of ocular flora after treatment with eyedrops containing 0.6% povidone-iodine in the eye of patients undergoing routine cataract surgery. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Endophthalmitis Following Cataract Surgery
- What is being tested?
- IODIM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 6 sitesItaly
- Study dates
- 8 Jan 2018to 30 Mar 2019
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Males and females aged between 40 and 80 years
- Patients who are candidates for cataract extraction
Who cannot join
- Males and females under 40 years and over 80 years
- Previous diseases of the eye, ocular surface and thyroid disease
- Known hypersensitivity to the product
- Presence of autoimmune diseases
- Pregnancy or breast-feeding
- Participation in other clinical studies
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Oftalmologia Universitaria Ospedale Policlinico di Bari
Bari, BA, 70120
Clinica Oculistica Azienda Ospedaliero-Universitaria, Presidio Ospedaliero G. Rodolico
Catania, CT, 95123
Ospedale Sacra Famiglia Fatebenefratelli
Erba, Como, 22036
Centro di Microchirurgia Ambulatoriale di Monza
Monza, MB, 20900
Casa di Cura Villa Valeria di Roma
Roma, RM, 00141
Ospedale San Carlo di Nancy
Roma, RM, 00165
About this study
Official title: Evaluation of Conjunctival Flora Alteration in Patients Undergoing Cataract Surgery
The purpose of the present study is to elucidate the qualitative and quantitative variation of ocular flora after treatment with eyedrops containing 0.6% povidone-iodine in the eye of patients undergoing routine cataract surgery.
Read the detailed description
Two conjunctival swabs will be executed at 3 days before and at the day of routine cataract surgery in each eye of patients undergoing routine cataract surgery. After the collection of the first conjunctival swab a three-days treatment with eyedrops containing 0.6% povidone-iodine in the eye undergoing routine cataract surgery will be performed. Bacterial isolates will be identified by using standard microbiological protocols and total bacterial load will be determined at the two different time points. In vitro susceptibility testing to determine methicillin resistance in isolated Staphylococcus species will be performed. Controlateral eye of each patient will be used as control. Descriptive statistics will be calculated.
- Being tested
- IODIM
- Keywords
- Cataract, Endophthalmitis, Microbiological evaluation
- Medical subject headings
- Cataract, Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IODIMDevice
Eye drops containing polyvinylpyrrolidone-Iodine (PVP-Iodine), hyaluronic acid and triglycerides
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing routine cataract surgery | Experimental | Two eye drops containing PVP-Iodine instillation in the eye undergoing cataract surgery three times for three days before surgery.
Each patient was evaluated for conjunctival flora variation by means of two conjunctival swabs before starting the treatment and at the end of the treatment before the surgery. Receives: Device: IODIM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of bacterial load of Positive Culture in Subjects Scheduled for Cataract Surgery
Variation/Eradication of bacterial load in participants with positive culture at the screening visit. This variation/Eradication will be recorded at pre-surgical visit by means of a second collection of a conjunctival swab and culture analysis. This outcome will be assessed by comparing the number of participants undergoing eradication of their initial bacterial load or decrease of bacterial load after treatment.
Measured: Three days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start8 Jan 2018
- Primary completion29 Oct 2018
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endophthalmitis Following Cataract SurgeryStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each patient has self-control of the IODIM treatment in the eye undergoing to cataract surgery with the contralateral eye. Microbiological studies will be performed by means of conjunctival swabs evaluation.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Sacra Famiglia - Fatebenefratelli Erba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958292
- Sponsor's protocol ID
- OSFFE_OCU_IO18
- Status last verified
- May 2019
- First submitted
- 8 May 2019
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Conjunctival Flora Alteration in Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT03958292
- Acronym / sponsor ID
- OSFFE_OCU_IO18
- Keywords
- Cataract, Endophthalmitis, Microbiological evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ospedale Sacra Famiglia - Fatebenefratelli ErbaUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 22 May 2019 (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 purpose of the present study is to elucidate the qualitative and quantitative variation of ocular flora after treatment with eyedrops containing 0.6% povidone-iodine in the eye of patients undergoing routine cataract surgery.
Detailed description
Two conjunctival swabs will be executed at 3 days before and at the day of routine cataract surgery in each eye of patients undergoing routine cataract surgery. After the collection of the first conjunctival swab a three-days treatment with eyedrops containing 0.6% povidone-iodine in the eye undergoing routine cataract surgery will be performed. Bacterial isolates will be identified by using standard microbiological protocols and total bacterial load will be determined at the two different time points. In vitro susceptibility testing to determine methicillin resistance in isolated Staphylococcus species will be performed. Controlateral eye of each patient will be used as control. Descriptive statistics will be calculated.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each patient has self-control of the IODIM treatment in the eye undergoing to cataract surgery with the contralateral eye. Microbiological studies will be performed by means of conjunctival swabs evaluation.
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing routine cataract surgery | Experimental | Device: IODIMTwo eye drops containing PVP-Iodine instillation in the eye undergoing cataract surgery three times for three days before surgery. Each patient was evaluated for conjunctival flora variation by means of two conjunctival swabs before starting the treatment and at the end of the treatment before the surgery. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent
- Males and females aged between 40 and 80 years
- Patients who are candidates for cataract extraction
Key exclusion criteria (6 listed)
- Males and females under 40 years and over 80 years
- Previous diseases of the eye, ocular surface and thyroid disease
- Known hypersensitivity to the product
- Presence of autoimmune diseases
- Pregnancy or breast-feeding
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 |
|---|---|---|
| IODIMEye drops containing polyvinylpyrrolidone-Iodine (PVP-Iodine), hyaluronic acid and triglycerides | Device | Patients undergoing routine cataract surgery |
Primary outcome
Variation of bacterial load of Positive Culture in Subjects Scheduled for Cataract Surgery
Time frame: Three days of treatment
Variation/Eradication of bacterial load in participants with positive culture at the screening visit. This variation/Eradication will be recorded at pre-surgical visit by means of a second collection of a conjunctival swab and culture analysis. This outcome will be assessed by comparing the number of participants undergoing eradication of their initial bacterial load or decrease of bacterial load after treatment.
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 22 May 2019.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IODIM in people with Endophthalmitis Following Cataract Surgery, run by Ospedale Sacra Famiglia - Fatebenefratelli Erba at 6 sites in Italy.
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 6 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 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. 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.
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?
Variation of bacterial load of Positive Culture in Subjects Scheduled for Cataract Surgery (time frame: Three days of treatment). 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 22 May 2019.