Age-related Macular DegenerationNCT02951351
Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections
A study testing Proparacaine and Conjunctival culture in people with Age-related Macular Degeneration and Diabetic Macular Edema, run by Mayo Clinic at 1 site in United States.
Trial summary
The specific aims of this study are to compare patient experience with and without a proparacaine drop after povidone iodine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-related Macular Degeneration, Diabetic Macular Edema, Injection Site
- What is being tested?
- Proparacaine and Conjunctival culture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing intravitreal injection who do not have active eye infections
- greater than 18 years of age
Who cannot join
- patients younger than 18 years of age
- patients with active eye infections
Trial locations and contacts
1 site in 1 country.
About this study
The specific aims of this study are to compare patient experience with and without a proparacaine drop after povidone iodine.
Read the detailed description
To ensure the extra drop does not interfere with antisepsis, conjunctival cultures will be obtained from patients undergoing intravitreal injection before and after the application of the extra eye drop. Patients will be randomized to undergo additional topical analgesia during intravitreal injection vs. the standard amount of topical analgesia. Cultures of the eyelid/conjunctiva will be taken to ensure that the additional topical analgesia does not interfere with antisepsis.
- Conditions
- Age-related Macular Degeneration, Diabetic Macular Edema, Injection Site, Injection Site Infection, Pain, Postoperative
- Being tested
- Proparacaine, Conjunctival culture
- Medical subject headings
- Macular Degeneration, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProparacaineDrug
Also called alcaine
Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.
Conjunctival cultureProcedure or surgery
Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
| Study group | Role | What they receive |
|---|---|---|
| Standard procedure + Culture | Active comparator | Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed. Receives: Procedure: Conjunctival culture |
| Proparacaine + Culture | Experimental | Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed. Receives: Drug: Proparacaine; Procedure: Conjunctival culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Study Participants With Positive Conjunctival Culture
Conjunctival samples were collected after participants received either an additional drop of proparacaine or povidone iodine. Bacterial cultures were performed from conjunctival samples by the Mayo Clinic Microbiology laboratory. Bacterial species identification was performed on any and all bacteria that grew.
Measured: pre-injection
Pain at the Time of Injection
Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the lesser the perceived pain, the higher the score, the higher the perceived pain.
Measured: post-injection
Secondary outcomes (6)
Residual Pain From Intravitreal Injection
Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the lesser the residual pain, the higher the score, the higher the residual pain.
Measured: post-injection
Overall Impression of Visit for Intravitreal Injection
Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the more positive impression of the visit, the higher the score, the less positive impression of the visit.
Measured: post-injection
Impression of Pre-injection Preparations
Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey consisted of 6 questions and was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the more positive impression of the preparation process, the higher the score, the less positive impression of the preparation process..
Measured: post-injection
Comfort With Intravitreal Injection Standard Procedure
Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the more comfortable the subject was with the procedure, the higher the score, the less comfortable the subject was with the procedure.
Measured: post-injection
Expectation Intravitreal Injection Will Have Negative Consequences on Subject Health
Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. A lower score indicated subjects did not expect the injection would negatively affect their overall health. Higher scores indicated subjects expected the injection would negatively affect their overall health.
Measured: post-injection
Expectation the Injection Will Contribute to Curing/Improving Eye Condition
Patients were asked to rate their expectation on the extent to which the intravitreal injections would contribute to curing or improving their eye condition. The question was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a negative response (not at all) and 10 was a positive response (to a large extent). A low score indicated the subject did not expect the injection would contribute to curing or improving the eye condition while a high score indicated the subject did expect the injection will help to cure or improve the eye condition.
Measured: post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start12 Oct 2016
- Primary completion1 Feb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- VitreoRetinal Surgery, PA, Research to Prevent Blindness
- Responsible party
- Sponsor
- Investigators
- Jose S Pulido, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951351
- Sponsor's protocol ID
- 16-004063
- Status last verified
- Apr 2023
- First submitted
- 29 Oct 2016
- Last updated
- 12 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Isenberg SJ, Apt L, Yoshimori R, Khwarg S. Chemical preparation of the eye in ophthalmic surgery. IV. Comparison of povidone-iodine on the conjunctiva with a prophylactic antibiotic. Arch Ophthalmol. 1985 Sep;103(9):1340-2. doi: 10.1001/archopht.1985.01050090092039.
PubMed 2994609Apt L, Isenberg S, Yoshimori R, Paez JH. Chemical preparation of the eye in ophthalmic surgery. III. Effect of povidone-iodine on the conjunctiva. Arch Ophthalmol. 1984 May;102(5):728-9. doi: 10.1001/archopht.1984.01040030584025.
PubMed 6721765Oguz H, Oguz E, Karadede S, Aslan G. The antibacterial effect of topical anesthetic proparacaine on conjunctival flora. Int Ophthalmol. 1999;23(2):117-20. doi: 10.1023/a:1026567912389.
PubMed 11196120van Asten F, van Middendorp H, Verkerk S, Breukink MB, Lomme RM, Hoyng CB, Evers AW, Klevering BJ. ARE INTRAVITREAL INJECTIONS WITH ULTRATHIN 33-G NEEDLES LESS PAINFUL THAN THE COMMONLY USED 30-G NEEDLES? Retina. 2015 Sep;35(9):1778-85. doi: 10.1097/IAE.0000000000000550.
PubMed 25901838
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections
- ClinicalTrials.gov ID
- NCT02951351
- Acronym / sponsor ID
- 16-004063
- Conditions
- Age-related Macular Degeneration, Diabetic Macular Edema, Injection Site, Injection Site Infection, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- VitreoRetinal Surgery, PA, Research to Prevent Blindness
- Study start
- 12 Oct 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Posted 25 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aims of this study are to compare patient experience with and without a proparacaine drop after povidone iodine.
Detailed description
To ensure the extra drop does not interfere with antisepsis, conjunctival cultures will be obtained from patients undergoing intravitreal injection before and after the application of the extra eye drop. Patients will be randomized to undergo additional topical analgesia during intravitreal injection vs. the standard amount of topical analgesia. Cultures of the eyelid/conjunctiva will be taken to ensure that the additional topical analgesia does not interfere with antisepsis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard procedure + Culture | Active comparator | Procedure: Conjunctival culturePatients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed. |
| Proparacaine + Culture | Experimental | Drug: Proparacaine, Procedure: Conjunctival culturePatients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing intravitreal injection who do not have active eye infections
- greater than 18 years of age
Key exclusion criteria (2 listed)
- patients younger than 18 years of age
- patients with active eye infections
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 |
|---|---|---|
| ProparacaineAlso: alcaineExtra proparacaine will be applied to the conjunctival surface to determine its role in patient experience. | Drug | Proparacaine + Culture |
| Conjunctival cultureConjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis. | Procedure or surgery | Proparacaine + Culture, Standard procedure + Culture |
Primary outcome
Number of Study Participants With Positive Conjunctival Culture
Time frame: pre-injection
Conjunctival samples were collected after participants received either an additional drop of proparacaine or povidone iodine. Bacterial cultures were performed from conjunctival samples by the Mayo Clinic Microbiology laboratory. Bacterial species identification was performed on any and all bacteria that grew.
Pain at the Time of Injection
Time frame: post-injection
Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the lesser the perceived pain, the higher the score, the higher the perceived pain.
6 secondary outcomes
Residual Pain From Intravitreal Injection
Time frame: post-injection
Overall Impression of Visit for Intravitreal Injection
Time frame: post-injection
Impression of Pre-injection Preparations
Time frame: post-injection
Comfort With Intravitreal Injection Standard Procedure
Time frame: post-injection
Expectation Intravitreal Injection Will Have Negative Consequences on Subject Health
Time frame: post-injection
Expectation the Injection Will Contribute to Curing/Improving Eye Condition
Time frame: post-injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2994609Isenberg SJ, Apt L, Yoshimori R, Khwarg S. Chemical preparation of the eye in ophthalmic surgery. IV. Comparison of povidone-iodine on the conjunctiva with a prophylactic antibiotic. Arch Ophthalmol. 1985 Sep;103(9):1340-2. doi: 10.1001/archopht.1985.01050090092039.
- Background: PubMed 6721765Apt L, Isenberg S, Yoshimori R, Paez JH. Chemical preparation of the eye in ophthalmic surgery. III. Effect of povidone-iodine on the conjunctiva. Arch Ophthalmol. 1984 May;102(5):728-9. doi: 10.1001/archopht.1984.01040030584025.
- Background: PubMed 11196120Oguz H, Oguz E, Karadede S, Aslan G. The antibacterial effect of topical anesthetic proparacaine on conjunctival flora. Int Ophthalmol. 1999;23(2):117-20. doi: 10.1023/a:1026567912389.
- Background: PubMed 25901838van Asten F, van Middendorp H, Verkerk S, Breukink MB, Lomme RM, Hoyng CB, Evers AW, Klevering BJ. ARE INTRAVITREAL INJECTIONS WITH ULTRATHIN 33-G NEEDLES LESS PAINFUL THAN THE COMMONLY USED 30-G NEEDLES? Retina. 2015 Sep;35(9):1778-85. doi: 10.1097/IAE.0000000000000550.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Jose S Pulido, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proparacaine and Conjunctival culture in people with Age-related Macular Degeneration and Diabetic Macular Edema, run by Mayo Clinic at 1 site in United States.
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 2 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 12 Apr 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Study Participants With Positive Conjunctival Culture (time frame: pre-injection). The study lists 2 primary outcomes in all. 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 NCT02951351, 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 12 Apr 2023.