Intravitreal InjectionNCT05615805
The Effect of Ocular Rinse Volume on Surface Irritation After Intravitreal Injections
A study testing OSDI questionnaire and SPEEDII questionnaire in people with Intravitreal Injection and Ocular Rinse, run by University of Oklahoma at 1 site in United States.
Trial summary
This is the first randomized controlled trial looking into post-injection rinse volume of standard ophthalmic eyewash and its affect on patient comfort up to 72 hours after injections. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Intravitreal Injection, Ocular Rinse, Age-Related Macular Degeneration
- What is being tested?
- OSDI questionnaire and SPEEDII questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 1 Oct 2021
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- choroidal neovascular membrane or cystoid macular edema requiring intravitreal injections for treatment.
Who cannot join
- active ocular infection, eyelid trauma, graft versus host disease, thyroid eye disease, pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104
About this study
Official title: The Effect of Ocular Rinse Volume on Surface Irritation After Povidone-iodine Preparation for Intravitreal Injections: A Randomized Controlled Trial
This is the first randomized controlled trial looking into post-injection rinse volume of standard ophthalmic eyewash and its affect on patient comfort up to 72 hours after injections.
Read the detailed description
Purpose To evaluate whether the volume of wash out rinse after povidone iodine (PI) application for intravitreal injections (IVI) affects patients' ocular surface irritation.
Methods This was a prospective, single-masked, randomized-controlled trial consisting of 142 subjects . A total of 51, 45, and 46 patients received 3-mL, 10-mL, and 15-mL of ocular rinse respectively. Reductions in the Ocular Surface Disease Index (OSDI) and the Standardized Patient Evaluation of Eye Dryness II (SPEED II) surveys, conducted before and at 24-72 hours post-injection, were analyzed.
- Conditions
- Intravitreal Injection, Ocular Rinse, Age-Related Macular Degeneration, Diabetic Macular Edema, Cystoid Macular Edema
- Being tested
- OSDI questionnaire, SPEEDII questionnaire
- Medical subject headings
- Macular Degeneration, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSDI questionnaireOther
Ocular Surface Disease Index
SPEEDII questionnaireOther
Standardized Patient Evaluation of Eye Dryness II questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 3-mL washout with saline based ocular rinse post injection | Experimental | Not described Receives: Other: OSDI questionnaire; Other: SPEEDII questionnaire |
| 10-mL washout with saline based ocular rinse post injection | Experimental | Not described Receives: Other: OSDI questionnaire; Other: SPEEDII questionnaire |
| 15-mL washout with saline based ocular rinse post injection | Experimental | Not described Receives: Other: OSDI questionnaire; Other: SPEEDII questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index
Patient symptoms questionnaire, range 0-28, higher score is associated with worse outcome.
Measured: 24-72 hours after injection
Secondary outcomes (1)
Standardized Patient Evaluation of Eye Dryness II
Patient symptoms questionnaire, range 0-48, higher score is associated with worse outcome.
Measured: 24-72 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Mar 2021
- Primary completion30 Jul 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravitreal InjectionStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615805
- Sponsor's protocol ID
- IRB #9810
- Status last verified
- Apr 2023
- First submitted
- 26 Oct 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on their required use of the data
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ocular Rinse Volume on Surface Irritation After Povidone-iodine Preparation for Intravitreal Injections: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05615805
- Acronym / sponsor ID
- IRB #9810
- Conditions
- Intravitreal Injection, Ocular Rinse, Age-Related Macular Degeneration, Diabetic Macular Edema, Cystoid Macular Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 14 Nov 2022 (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.
This is the first randomized controlled trial looking into post-injection rinse volume of standard ophthalmic eyewash and its affect on patient comfort up to 72 hours after injections.
Detailed description
Purpose To evaluate whether the volume of wash out rinse after povidone iodine (PI) application for intravitreal injections (IVI) affects patients' ocular surface irritation.
Methods This was a prospective, single-masked, randomized-controlled trial consisting of 142 subjects . A total of 51, 45, and 46 patients received 3-mL, 10-mL, and 15-mL of ocular rinse respectively. Reductions in the Ocular Surface Disease Index (OSDI) and the Standardized Patient Evaluation of Eye Dryness II (SPEED II) surveys, conducted before and at 24-72 hours post-injection, were analyzed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3-mL washout with saline based ocular rinse post injection | Experimental | Other: OSDI questionnaire, Other: SPEEDII questionnaire |
| 10-mL washout with saline based ocular rinse post injection | Experimental | Other: OSDI questionnaire, Other: SPEEDII questionnaire |
| 15-mL washout with saline based ocular rinse post injection | Experimental | Other: OSDI questionnaire, Other: SPEEDII questionnaire |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- choroidal neovascular membrane or cystoid macular edema requiring intravitreal injections for treatment.
Key exclusion criteria (1 listed)
- active ocular infection, eyelid trauma, graft versus host disease, thyroid eye disease, pregnancy.
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 |
|---|---|---|
| OSDI questionnaireOcular Surface Disease Index | Other | 10-mL washout with saline based ocular rinse post injection, 15-mL washout with saline based ocular rinse post injection, 3-mL washout with saline based ocular rinse post injection |
| SPEEDII questionnaireStandardized Patient Evaluation of Eye Dryness II questionnaire | Other | 10-mL washout with saline based ocular rinse post injection, 15-mL washout with saline based ocular rinse post injection, 3-mL washout with saline based ocular rinse post injection |
Primary outcome
Ocular Surface Disease Index
Time frame: 24-72 hours after injection
Patient symptoms questionnaire, range 0-28, higher score is associated with worse outcome.
1 secondary outcome
Standardized Patient Evaluation of Eye Dryness II
Time frame: 24-72 hours after injection
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 25 Apr 2023.
- Individual participant dataSharing planned: Undecided. Depending on their required use of the data
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OSDI questionnaire and SPEEDII questionnaire in people with Intravitreal Injection and Ocular Rinse, run by University of Oklahoma 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 1 inclusion and 1 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 25 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?
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?
Ocular Surface Disease Index (time frame: 24-72 hours after injection). 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 25 Apr 2023.