Macular Degeneration
Conditions
Keywords
Macular Degeneration, Intravitreal injections, Eye anesthesia-Topical/subconjunctival, Eye-surgical procedures, Ophthalmologic anesthesia methods
Brief summary
This study is designed to compare four currently used types of anesthesia used prior to intravitreal injection in order to evaluate the most effective method of anesthesia in reducing pain and discomfort associated with intravitreal injections.
Detailed description
Over the last several years intravitreal injection of pharmacologic agents has become a common procedure in ophthalmology. Injected agents include steroid, antibiotics, and most recently anti-VEGF agents. There are many methods of preparing a patient for intravitreal injection. While there are guidelines for infection prophylaxis, there is currently no standard of care or consensus on which method of anesthesia is most effective in reducing pain and discomfort associated with intravitreal injections. Patients who have received prior injections and are scheduled to continue regular injections will be randomized to utilize one of four types of anesthetic treatment for each of 4 treatment periods,so that each subject receives all four types of anesthesia over the course of the study. The order of the anesthetic treatment the subject will receive prior to each planned intravitreal injection during the study period will be different for each subject. This will decrease the effect of extraneous variables from influencing subjective pain scores. Following each procedure, patients will fill out an analog pain scale questionnaire, grading the discomfort of receiving both the anesthesia and the injection(on separate 0-10 scales). The anesthetic methods used will include: 1.) Drops of Proparacaine on the eye, 2.) Drops of Tetracaine on the eye, 3.) A cotton sponge (pledget) soaked with Lidocaine 4% placed over the conjunctiva and 4.)A subconjunctival injection with 2% Lidocaine. The subjects' number and type of visits, tests and treatments will be standard of care and will not be different due to the study. The total time for the treatment part of the study coincides with four injections (1 injection per month) or approximately 4 months and will be followed for up to 6 months.
Interventions
Drops of Proparacaine on the eye, administered as described in the package insert
DRUGTetracaine Ophthalmic
Drops of Tetracaine on the eye, administered as described in the package insert
DRUGLidocaine 4%
A cotton sponge(pledget)soaked with Lidocaine 4% placed over the conjunctiva
A subconjunctival injection of Lidocaine 2%
Sponsors
Lahey Clinic
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparcacaine used prior to Injection 1; Tetracaine used prior to Injection 2; Lidocaine sponge used prior to Injection 3; Lidocaine suconjunctival injection used prior to Injection 4).
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female \> 40 years of age * Diagnosis of age-related macular degeneration * History of at least 1 intravitreal injection in the past in either eye * Written informed consent has been obtained
Exclusion criteria
* Known allergy or sensitivity to the study medications(s), it's components, or other agents required for the study procedures(e.g. Povidone iodine)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort Associated With the Intravitreal Injection | 16 weeks | Discomfort Associated With the Intravitreal Injection using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort From Anesthesia Used Prior to Intravitreal Injections | 16 weeks | Discomfort from Anesthesia used prior to Intravitreal Injections using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10). |
Countries
United States
Participant flow
Pre-assignment details
28 participants enrolled in this study. Once 24 subjects completed the study, the remaining 4 subjects were not required to complete the study, therefore, their data was not collected for this analysis.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparcacaine used prior to Injection 1; Tetracaine used prior to Injection 2; Lidocaine sponge used prior to Injection 3; Lidocaine suconjunctival injection used prior to Injection 4). | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 13 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Discomfort Associated With the Intravitreal Injection
Discomfort Associated With the Intravitreal Injection using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10)
Time frame: 16 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants | Discomfort Associated With the Intravitreal Injection | Lidocaine 4% | 3 units on a scale |
| All Participants | Discomfort Associated With the Intravitreal Injection | Lidocaine 2% Injectable Solution | 2.3 units on a scale |
| All Participants | Discomfort Associated With the Intravitreal Injection | Proparacaine Ophthalmic | 2.8 units on a scale |
| All Participants | Discomfort Associated With the Intravitreal Injection | Tetracaine Ophthalmic | 3.1 units on a scale |
Comparison: A comparison of injection discomfort using mean pain scores for all 4 anesthesia intervention agents used in this study.p-value: 0.28single factor analysis of variance
Secondary
Discomfort From Anesthesia Used Prior to Intravitreal Injections
Discomfort from Anesthesia used prior to Intravitreal Injections using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10).
Time frame: 16 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants | Discomfort From Anesthesia Used Prior to Intravitreal Injections | Lidocaine 4% | 1.4 units on a scale |
| All Participants | Discomfort From Anesthesia Used Prior to Intravitreal Injections | Lidocaine 2% Injectable Solution | 1.6 units on a scale |
| All Participants | Discomfort From Anesthesia Used Prior to Intravitreal Injections | Proparacaine Ophthalmic | 0.7 units on a scale |
| All Participants | Discomfort From Anesthesia Used Prior to Intravitreal Injections | Tetracaine Ophthalmic | 1.0 units on a scale |
Comparison: A comparison of discomfort of all 4 anesthesia intervention agents used in this study using mean pain scores.p-value: 0.17single factor analysis of variance