PainNCT05640895
Intravitreal Injection Site and Perceived Pain
An observational study of Pain, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The objective of this study is to explore the perception of pain during intravitreal injection related to the distance of the entry site from the limbus. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Intravitreal injection site
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2022to 9 Sep 2024
- Phase
- Observational
- 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
Study population: Subjects will be from university eye clinics scheduled to undergo intravitreal injections
Who may be able to join
- Age 18 -100 years
- Diagnosis of diabetic macular edema, age related macular degeneration, or retinal vein occlusion
- Treated with bevacizumab, ranibizumab, aflibercept
- The need for at least two intravitreal injections
- Pseudophakia
Who cannot join
- Texas Department of Corrections medical records
- Under 18 years-of-age
- First intravitreal injection experience of patient
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: The Effect of Entry Site Distance From Limbus on Perceived Pain During Intravitreal Injection of Anti-VEGF (Vascular Endothelial Growth Factor) Agents
The objective of this study is to explore the perception of pain during intravitreal injection related to the distance of the entry site from the limbus.
Read the detailed description
In this pilot cross-over study, the investigators aim at exploring a factor not studied yet on the perception of pain during the injection procedure, and that is the distance of the entry site from the limbus.
Study population: Pseudophakic patients needing multiple intravitreal injections. In case of bilateral eligibility, one eye per patient will be included (randomly- based on a random chart).
Intervention: two injections per eye, will be included in the study. All steps of the technique will be similar between the two injections except for the entry site distance from the limbus, which will be 3.5 in one and 4.00 mm in the other. To prevent bias, the first injection entry distance will be randomly selected (based on a randomized chart).
The patient is blind to the entry distance, and a questionnaire with a visual analog pain scale will be given to the patient by a technician (to prevent any bias) to be filled after the injection. The analog pain scale is a scale of numbers from 0 to 10 representing the degree of patient's perceived pain. A score of 0 indicates no perception of pain; a score of 10 indicates a perception of the worst pain possible. The scale is also illustrated with face emojis corresponding to a written description of pain perception from no perception of pain, represented by a green, fully smiling face to perception of the worst pain possible, represented by a red, crying, fully frowning face.
- Conditions
- Pain
- Being tested
- Intravitreal injection site
- Keywords
- Intravitreal injection, Retinal diseases, Age-related macular degeneration, Diabetic retinopathy, Retinal vein occlusion, Limbus, Quadrants (regions) of the eye, Injection site, Pseudophakic/aphakic eyes, Phakic eyes, Pars plana, Ciliary body, Vitrectomy, Crystalline lens, Retina, Bevacizumab, Ranibizumab, Aflibercept, Diabetic macular edema, Anti-VEGF (Vascular Endothelial Growth Factor)
- Medical subject headings
- Pain, Retinal Diseases, Macular Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion, Aphakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection siteProcedure or surgery
Intravitreal injections will be made at varying sites; patients will report on pain perception
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual scale analogues for pain
Self-reported perception of pain according to analogue pain scale. The analog pain scale is a scale of numbers from 0 to 10 representing the degree of patient's perceived pain. A score of 0 indicates no perception of pain; a score of 10 indicates a perception of the worst pain possible. The scale is also illustrated with face emojis corresponding to a written description of pain perception from no perception of pain, represented by a green, fully smiling face to perception of the worst pain possible, represented by a red, crying, fully frowning face.
Measured: Immediately post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start14 Nov 2022
- Primary completion18 Dec 2023
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Touka K Banaee, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640895
- Sponsor's protocol ID
- 22-0228
- Status last verified
- Jan 2025
- First submitted
- 28 Nov 2022
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peyman GA, Lad EM, Moshfeghi DM. Intravitreal injection of therapeutic agents. Retina. 2009 Jul-Aug;29(7):875-912. doi: 10.1097/IAE.0b013e3181a94f01.
PubMed 19584648Gambrell J, Schaal S. Topical anesthesia for intravitreal injection. Expert Opin Drug Deliv. 2012 Jul;9(7):731-3. doi: 10.1517/17425247.2012.685156. Epub 2012 Jun 4.
PubMed 22657949Tewari A, Shah GK, Dhalla MS, Blinder KJ. Surface anesthesia for office-based retinal procedures. Retina. 2007 Jul-Aug;27(6):804-5. doi: 10.1097/IAE.0b013e31804b4081. No abstract available.
PubMed 17621193Karimi S, Mosavi SA, Jadidi K, Nikkhah H, Kheiri B. Which quadrant is less painful for intravitreal injection? A prospective study. Eye (Lond). 2019 Feb;33(2):304-312. doi: 10.1038/s41433-018-0208-y. Epub 2018 Sep 10.
PubMed 30202072Fan J, Guiseppi R, Digbeu B, Banaee T. Perception of pain during intravitreal injections: a clinical trial on the effect of entry site distance from the limbus on perceived pain. Int J Retina Vitreous. 2025 Dec 22;12(1):13. doi: 10.1186/s40942-025-00769-z.
PubMed 41430626
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Entry Site Distance From Limbus on Perceived Pain During Intravitreal Injection of Anti-VEGF (Vascular Endothelial Growth Factor) Agents
- ClinicalTrials.gov ID
- NCT05640895
- Acronym / sponsor ID
- 22-0228
- Conditions
- Pain
- Keywords
- Intravitreal injection, Retinal diseases, Age-related macular degeneration, Diabetic retinopathy, Retinal vein occlusion, Limbus, Quadrants (regions) of the eye, Injection site
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 7 Dec 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.
The objective of this study is to explore the perception of pain during intravitreal injection related to the distance of the entry site from the limbus.
Detailed description
In this pilot cross-over study, the investigators aim at exploring a factor not studied yet on the perception of pain during the injection procedure, and that is the distance of the entry site from the limbus.
Study population: Pseudophakic patients needing multiple intravitreal injections. In case of bilateral eligibility, one eye per patient will be included (randomly- based on a random chart).
Intervention: two injections per eye, will be included in the study. All steps of the technique will be similar between the two injections except for the entry site distance from the limbus, which will be 3.5 in one and 4.00 mm in the other. To prevent bias, the first injection entry distance will be randomly selected (based on a randomized chart).
The patient is blind to the entry distance, and a questionnaire with a visual analog pain scale will be given to the patient by a technician (to prevent any bias) to be filled after the injection. The analog pain scale is a scale of numbers from 0 to 10 representing the degree of patient's perceived pain. A score of 0 indicates no perception of pain; a score of 10 indicates a perception of the worst pain possible. The scale is also illustrated with face emojis corresponding to a written description of pain perception from no perception of pain, represented by a green, fully smiling face to perception of the worst pain possible, represented by a red, crying, fully frowning face.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be from university eye clinics scheduled to undergo intravitreal injections
Key inclusion criteria (5 listed)
- Age 18 -100 years
- Diagnosis of diabetic macular edema, age related macular degeneration, or retinal vein occlusion
- Treated with bevacizumab, ranibizumab, aflibercept
- The need for at least two intravitreal injections
- Pseudophakia
Key exclusion criteria (3 listed)
- Texas Department of Corrections medical records
- Under 18 years-of-age
- First intravitreal injection experience of patient
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 |
|---|---|---|
| Intravitreal injection siteIntravitreal injections will be made at varying sites; patients will report on pain perception | Procedure or surgery | – |
Primary outcome
Visual scale analogues for pain
Time frame: Immediately post-injection
Self-reported perception of pain according to analogue pain scale. The analog pain scale is a scale of numbers from 0 to 10 representing the degree of patient's perceived pain. A score of 0 indicates no perception of pain; a score of 10 indicates a perception of the worst pain possible. The scale is also illustrated with face emojis corresponding to a written description of pain perception from no perception of pain, represented by a green, fully smiling face to perception of the worst pain possible, represented by a red, crying, fully frowning face.
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 31 Jan 2025.
- Results publication: PubMed 19584648Peyman GA, Lad EM, Moshfeghi DM. Intravitreal injection of therapeutic agents. Retina. 2009 Jul-Aug;29(7):875-912. doi: 10.1097/IAE.0b013e3181a94f01.
- Results publication: PubMed 22657949Gambrell J, Schaal S. Topical anesthesia for intravitreal injection. Expert Opin Drug Deliv. 2012 Jul;9(7):731-3. doi: 10.1517/17425247.2012.685156. Epub 2012 Jun 4.
- Results publication: PubMed 17621193Tewari A, Shah GK, Dhalla MS, Blinder KJ. Surface anesthesia for office-based retinal procedures. Retina. 2007 Jul-Aug;27(6):804-5. doi: 10.1097/IAE.0b013e31804b4081. No abstract available.
- Results publication: PubMed 30202072Karimi S, Mosavi SA, Jadidi K, Nikkhah H, Kheiri B. Which quadrant is less painful for intravitreal injection? A prospective study. Eye (Lond). 2019 Feb;33(2):304-312. doi: 10.1038/s41433-018-0208-y. Epub 2018 Sep 10.
- Derived from this study: PubMed 41430626Fan J, Guiseppi R, Digbeu B, Banaee T. Perception of pain during intravitreal injections: a clinical trial on the effect of entry site distance from the limbus on perceived pain. Int J Retina Vitreous. 2025 Dec 22;12(1):13. doi: 10.1186/s40942-025-00769-z.
- 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. This study is not recruiting at the moment.
Touka K Banaee, MD principal investigator
University of Texas
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 Pain, run by The University of Texas Medical Branch, Galveston 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 5 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 31 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 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?
Visual scale analogues for pain (time frame: Immediately post-injection). 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 NCT05640895, which also lists 5 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 31 Jan 2025.