Eye DiseaseZAMI-PRONCT06771908
THE ROLE OF HEXAMIDINE DIISETHIONATE (ZAMIDINE®) 1MG/ML 0.6ML EYE DROPS IN THE PROPHYLAXIS OF SURGERY OFTALMIC
An observational study of Eye Disease and Conjunctivitis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Data will be gathered from patients who report having any kind of recurrent conjunctivitis and who, in accordance with clinical practice, are scheduled to have intravitreal injections, glaucoma surgery, cataract surgery, vitrectomy, combined cataract and vitrectomy, or corneal transplantation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Eye Disease, Conjunctivitis
- What is being tested?
- Conjunctival Swab
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2025to 1 Feb 2026
- Phase
- Observational
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Saranno inclusi nello studio i pazienti che devono eseguire qualsiasi intervento di chirurgia oftalmica minore o maggiore con anamnesi positiva di congiuntiviti ricorrenti, secondo pratica clinica e che necessitano di profilassi chirurgica antisettica.
Who may be able to join
- Age 18 years or older, male and female;
- Patient requiring ophthalmic surgery (intravitreal injections, glaucoma surgery, cataract surgery, vitrectomy, combined cataract and vitrectomy, corneal transplantation) and in need of antiseptic surgical prophylaxis (e.g., Zamidine®)
- Positive history of recurrent conjunctivitis in the eye requiring surgery.
- Written informed consent.
Who cannot join
- Age < 18 years;
- Refusal to give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Prof. Stanislao Rizzo
Rome, 00168
Stanislao Rizzo, MD,PhD
About this study
Data will be gathered from patients who report having any kind of recurrent conjunctivitis and who, in accordance with clinical practice, are scheduled to have intravitreal injections, glaucoma surgery, cataract surgery, vitrectomy, combined cataract and vitrectomy, or corneal transplantation.
The data will be obtained using pseudonyms from the patients' medical records and will include the outcomes of swabs and surgeries performed in accordance with clinical practice for the patient's condition.
Read more
The following swabs will be taken into consideration for data analysis:
Four days before to surgery, a conjunctival swab is used to check for the presence and load of species that do not make up the typical conjunctival flora (Baseline-T0).
On the day of operation, a conjunctival swab is taken before to entering the recovery room (T1).
Following three minutes of 5% iodopovidone instillation in the eye to be operated on, a conjunctival swab (T2) was used.
Additionally, we will gather follow-up data from the medical record 24 and 30 hours after surgery (at day 34 +/- 7 days).
Read the detailed description
To determine if Zamidine® reduces ocular surface bacterial flora in surgical prophylaxis.
Secondary goals. To quantify and qualitatively evaluate ocular surface bacterial flora,
- Compare bacterial load before and after surgery with 5% iodopovidone.
- Determine sample endophthalmitis incidence. The study will include patients who are scheduled for intravitreal injections, glaucoma surgery, cataract surgery, vitrectomy, combined cataract and vitrectomy, corneal transplantation, and any type of recurrent conjunctivitis.
Data from patients' medical records will be pseudonymized and contain swabs and operation findings according to clinical practice for their condition.
Following swabs will be analyzed for data:
- a conjunctival swab four days before surgery to detect and quantify non-native organisms.
A conjunctival swab before operation day's recovery room (T1).
- a conjunctival swab (T2) after 3 minutes of 5% iodopovidone in the operative eye.
Follow-up data at 24 and 30 days after surgery (day 34 +- 7 days) will be collected from the medical record.
- Conditions
- Eye Disease, Conjunctivitis
- Being tested
- Conjunctival Swab
- Keywords
- Ophthalmic prophylaxis, Surgery, Ophthalmic Swab
- Medical subject headings
- Eye Diseases, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conjunctival SwabDiagnostic test
CFU/ml by bacterial species before and after prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| Patients who need ophthalmic surgery | Patients with a history of recurrent conjunctivitis who are scheduled for minor or major ocular surgery. Receives: Diagnostic Test: Conjunctival Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial species before and after prophylaxis.
CFU/ml by bacterial species before and after prophylaxis.
Measured: 4 days before prophylaxis, the day of surgery before and after povidone-iodine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RIZZO STANISLAO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771908
- Sponsor's protocol ID
- 7172
- Acronym
- ZAMI-PRO
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Merani R, Hunyor AP. Endophthalmitis following intravitreal anti-vascular endothelial growth factor (VEGF) injection: a comprehensive review. Int J Retina Vitreous. 2015 Jul 21;1:9. doi: 10.1186/s40942-015-0010-y. eCollection 2015.
PubMed 27847602Speaker MG, Milch FA, Shah MK, Eisner W, Kreiswirth BN. Role of external bacterial flora in the pathogenesis of acute postoperative endophthalmitis. Ophthalmology. 1991 May;98(5):639-49; discussion 650. doi: 10.1016/s0161-6420(91)32239-5.
PubMed 2062496Peyman A, Hosseini M, Narimani T. Comparison of the Effects of Povidone-Iodine 5%, Polyhexamethylene Biguanide, and Chlorhexidine as a Preoperative Antiseptic in Endophthalmitis Prophylaxis in Patients Undergoing Phacoemulsification Cataract Surgery. Adv Biomed Res. 2020 Apr 22;9:15. doi: 10.4103/abr.abr_155_19. eCollection 2020.
PubMed 32775308Aragona P, Baudouin C, Benitez Del Castillo JM, Messmer E, Barabino S, Merayo-Lloves J, Brignole-Baudouin F, Inferrera L, Rolando M, Mencucci R, Rescigno M, Bonini S, Labetoulle M. The ocular microbiome and microbiota and their effects on ocular surface pathophysiology and disorders. Surv Ophthalmol. 2021 Nov-Dec;66(6):907-925. doi: 10.1016/j.survophthal.2021.03.010. Epub 2021 Apr 2.
PubMed 33819460
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE ROLE OF HEXAMIDINE DIISETHIONATE (ZAMIDINE®) 1MG/ML 0.6ML EYE DROPS IN THE PROPHYLAXIS OF SURGERY OFTALMIC
- ClinicalTrials.gov ID
- NCT06771908
- Acronym / sponsor ID
- ZAMI-PRO / 7172
- Conditions
- Eye Disease, Conjunctivitis
- Keywords
- Ophthalmic prophylaxis, Surgery, Ophthalmic Swab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 13 Jan 2025 (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.
Data will be gathered from patients who report having any kind of recurrent conjunctivitis and who, in accordance with clinical practice, are scheduled to have intravitreal injections, glaucoma surgery, cataract surgery, vitrectomy, combined cataract and vitrectomy, or corneal transplantation.
The data will be obtained using pseudonyms from the patients' medical records and will include the outcomes of swabs and surgeries performed in accordance with clinical practice for the patient's condition.
The following swabs will be taken into consideration for data analysis:
Four days before to surgery, a conjunctival swab is used to check for the presence and load of species that do not make up the typical conjunctival flora (Baseline-T0).
On the day of operation, a conjunctival swab is taken before to entering the recovery room (T1).
Following three minutes of 5% iodopovidone instillation in the eye to be operated on, a conjunctival swab (T2) was used.
Additionally, we will gather follow-up data from the medical record 24 and 30 hours after surgery (at day 34 +/- 7 days).
Detailed description
To determine if Zamidine® reduces ocular surface bacterial flora in surgical prophylaxis.
Secondary goals. To quantify and qualitatively evaluate ocular surface bacterial flora,
- Compare bacterial load before and after surgery with 5% iodopovidone.
- Determine sample endophthalmitis incidence. The study will include patients who are scheduled for intravitreal injections, glaucoma surgery, cataract surgery, vitrectomy, combined cataract and vitrectomy, corneal transplantation, and any type of recurrent conjunctivitis.
Data from patients' medical records will be pseudonymized and contain swabs and operation findings according to clinical practice for their condition.
Following swabs will be analyzed for data:
- a conjunctival swab four days before surgery to detect and quantify non-native organisms.
A conjunctival swab before operation day's recovery room (T1).
- a conjunctival swab (T2) after 3 minutes of 5% iodopovidone in the operative eye.
Follow-up data at 24 and 30 days after surgery (day 34 +- 7 days) will be collected from the medical record.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who need ophthalmic surgery | – | Diagnostic Test: Conjunctival SwabPatients with a history of recurrent conjunctivitis who are scheduled for minor or major ocular surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Saranno inclusi nello studio i pazienti che devono eseguire qualsiasi intervento di chirurgia oftalmica minore o maggiore con anamnesi positiva di congiuntiviti ricorrenti, secondo pratica clinica e che necessitano di profilassi chirurgica antisettica.
Key inclusion criteria (4 listed)
- Age 18 years or older, male and female;
- Patient requiring ophthalmic surgery (intravitreal injections, glaucoma surgery, cataract surgery, vitrectomy, combined cataract and vitrectomy, corneal transplantation) and in need of antiseptic surgical prophylaxis (e.g., Zamidine®)
- Positive history of recurrent conjunctivitis in the eye requiring surgery.
- Written informed consent.
Key exclusion criteria (2 listed)
- Age < 18 years;
- Refusal to give informed consent.
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 |
|---|---|---|
| Conjunctival SwabCFU/ml by bacterial species before and after prophylaxis. | Diagnostic test | Patients who need ophthalmic surgery |
Primary outcome
Bacterial species before and after prophylaxis.
Time frame: 4 days before prophylaxis, the day of surgery before and after povidone-iodine
CFU/ml by bacterial species before and after prophylaxis.
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 13 Jan 2025.
- Background: PubMed 27847602Merani R, Hunyor AP. Endophthalmitis following intravitreal anti-vascular endothelial growth factor (VEGF) injection: a comprehensive review. Int J Retina Vitreous. 2015 Jul 21;1:9. doi: 10.1186/s40942-015-0010-y. eCollection 2015.
- Background: PubMed 2062496Speaker MG, Milch FA, Shah MK, Eisner W, Kreiswirth BN. Role of external bacterial flora in the pathogenesis of acute postoperative endophthalmitis. Ophthalmology. 1991 May;98(5):639-49; discussion 650. doi: 10.1016/s0161-6420(91)32239-5.
- Background: PubMed 32775308Peyman A, Hosseini M, Narimani T. Comparison of the Effects of Povidone-Iodine 5%, Polyhexamethylene Biguanide, and Chlorhexidine as a Preoperative Antiseptic in Endophthalmitis Prophylaxis in Patients Undergoing Phacoemulsification Cataract Surgery. Adv Biomed Res. 2020 Apr 22;9:15. doi: 10.4103/abr.abr_155_19. eCollection 2020.
- Background: PubMed 33819460Aragona P, Baudouin C, Benitez Del Castillo JM, Messmer E, Barabino S, Merayo-Lloves J, Brignole-Baudouin F, Inferrera L, Rolando M, Mencucci R, Rescigno M, Bonini S, Labetoulle M. The ocular microbiome and microbiota and their effects on ocular surface pathophysiology and disorders. Surv Ophthalmol. 2021 Nov-Dec;66(6):907-925. doi: 10.1016/j.survophthal.2021.03.010. Epub 2021 Apr 2.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Disease and Conjunctivitis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 4 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: looking for participants now, as of the sponsor's last update on 13 Jan 2025. 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 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?
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 Stanislao Rizzo, MD, Prof (0630151, oculistica@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial species before and after prophylaxis. (time frame: 4 days before prophylaxis, the day of surgery before and after povidone-iodine). 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 NCT06771908, which also lists 4 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 13 Jan 2025.