Post Procedural Infection
Conditions
Brief summary
This three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA insertion
Detailed description
4.1 Study Population The study aims to enroll 20 patients undergoing bilateral SMILE. 4.1.1 Inclusion Criteria A patient's study eye must meet the following criteria to be eligible for inclusion in the study: * Age 18 years and older * Scheduled for bilateral SMILE surgery * Willing and able to comply with clinic visits and study related procedures * Willing and able to sign the informed consent form 4.1.2 Exclusion Criteria A patient who meets any of the following criteria will be excluded from the study: * Patients under the age of 18. * Pregnancy (must be ruled out in women of child-bearing age with pregnancy test) * Active infectious systemic disease * Active infectious ocular or extraocular disease * Obstructed nasolacrimal duct in the study eye(s) * Hypersensitivity to dexamethasone * Patients being treated with immunomodulating agents in the study eye(s) * Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Interventions
DRUGDexamethasone ophthalmic insert 0.4 mg
intracanalicular dexamethasone insert
DRUGTopical Prednisolone Acetate Ophthalmic Drops
Topical Prednisolone acetate ophthalmic drops per standard of care: Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue
Sponsors
William Wiley, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
First eye randomized for either topical prednisolone acetate (control eye) or lower eyelid canaliculus Dextenza insertion (study eye) and the contralateral eye receiving opposite treatment in the OR following SMILE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and older * Scheduled for bilateral SMILE surgery * Willing and able to comply with clinic visits and study related procedures * Willing and able to sign the informed consent form
Exclusion criteria
* Patients under the age of 18. * Pregnancy (must be ruled out in women of child-bearing age with pregnancy test) * Active infectious systemic disease * Active infectious ocular or extraocular disease * Obstructed nasolacrimal duct in the study eye(s) * Hypersensitivity to dexamethasone * Patients being treated with immunomodulating agents in the study eye(s) * Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Pain | Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90 | post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 (0 being no pain and 10 being the worst pain you could imagine) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Lines Lost From Best Corrected Visual Acuity | Baseline through Day 90 | After manifest refraction all units assessed for best corrected distance visual acuity using ETDRS. Number of lines seen was then converted to LogMar score (on a scale of -0.30 to 1.00 where smaller numbers indicate better vision and larger numbers indicate worse vision) to measure changes in Best Corrected Distance Visual Acuity between Baseline and Day 90 |
| Loss of Lines in Uncorrected Visual Acuity | Baseline to Day 7, Day 30 and Day 90 | All units assessed for uncorrected visual acuity using ETDRS. Number of lines seen was then converted to LogMar to measure changes in uncorrected visual acuity between Baseline and Day 90. |
| Post op Pain Management Per Eye | Day 0 to Day 90 | Count of participants requiring pain management from Day 0 to Day 90. |
| Patient Preference Between Groups | Day 7, Day 30 and Day 90 | As reported by patients choosing one of five options; Strongly preferred insert, preferred insert, no preference, preferred standard drop regimen, strongly preferred standard drop regimen. |
Countries
United States
Participant flow
Recruitment details
This prospective, randomized, fellow-eye controlled study was conducted at a single site (Clear Choice Custom LASIK Center) in 20 patients (40 eyes) with three surgeons between June 2020 and June 2021 and was performed according to guidelines established by the Declaration of Helsinki.
Pre-assignment details
Twenty-three patients were enrolled in the study. One patient failed screening and was not randomized. Two additional patients were randomized, but the Dextenza insert could not be successfully placed in the assigned eye at the time of surgery.
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Patients Enrolled patients who underwent SMILE surgery in both eyes with investigational treatment in one eye and standard of care treatment in the fellow eye. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
Baseline characteristics
| Characteristic | Enrolled Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 3 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Mean Change in Pain
post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 (0 being no pain and 10 being the worst pain you could imagine)
Time frame: Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90
Population: All subjects were seen through week 1; three were lost to follow up thereafter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexamethasone Ophthalmic Insert 0.4 mg | Mean Change in Pain | Day 1 | 0.95 Score on a scale from 0-10 | Standard Deviation 1.36 |
| Dexamethasone Ophthalmic Insert 0.4 mg | Mean Change in Pain | Day 30 | 0.41 Score on a scale from 0-10 | Standard Deviation 1.7 |
| Dexamethasone Ophthalmic Insert 0.4 mg | Mean Change in Pain | Day 7 | 0.47 Score on a scale from 0-10 | Standard Deviation 0.94 |
| Dexamethasone Ophthalmic Insert 0.4 mg | Mean Change in Pain | Day 90 | 0 Score on a scale from 0-10 | Standard Deviation 0 |
| Dexamethasone Ophthalmic Insert 0.4 mg | Mean Change in Pain | Pre-operative | 0.15 Score on a scale from 0-10 | Standard Deviation 0.5 |
| Topical Prednisolone Acetate Ophthalmic Drops | Mean Change in Pain | Day 90 | 0 Score on a scale from 0-10 | Standard Deviation 0 |
| Topical Prednisolone Acetate Ophthalmic Drops | Mean Change in Pain | Pre-operative | 0.20 Score on a scale from 0-10 | Standard Deviation 0.5 |
| Topical Prednisolone Acetate Ophthalmic Drops | Mean Change in Pain | Day 1 | 0.90 Score on a scale from 0-10 | Standard Deviation 1.12 |
| Topical Prednisolone Acetate Ophthalmic Drops | Mean Change in Pain | Day 7 | 0.37 Score on a scale from 0-10 | Standard Deviation 0.67 |
| Topical Prednisolone Acetate Ophthalmic Drops | Mean Change in Pain | Day 30 | 0.06 Score on a scale from 0-10 | Standard Deviation 0.24 |
Secondary
Loss of Lines in Uncorrected Visual Acuity
All units assessed for uncorrected visual acuity using ETDRS. Number of lines seen was then converted to LogMar to measure changes in uncorrected visual acuity between Baseline and Day 90.
Time frame: Baseline to Day 7, Day 30 and Day 90
Population: All subjects were seen through week 1; three were lost to follow up thereafter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexamethasone Ophthalmic Insert 0.4 mg | Loss of Lines in Uncorrected Visual Acuity | 1 week | -0.010 logMAR | Standard Deviation 0.0114 |
| Dexamethasone Ophthalmic Insert 0.4 mg | Loss of Lines in Uncorrected Visual Acuity | 1 month | -0.014 logMAR | Standard Deviation 0.181 |
| Dexamethasone Ophthalmic Insert 0.4 mg | Loss of Lines in Uncorrected Visual Acuity | 3 months | -0.071 logMAR | Standard Deviation 0.108 |
| Topical Prednisolone Acetate Ophthalmic Drops | Loss of Lines in Uncorrected Visual Acuity | 1 week | 0.013 logMAR | Standard Deviation 0.183 |
| Topical Prednisolone Acetate Ophthalmic Drops | Loss of Lines in Uncorrected Visual Acuity | 1 month | -0.026 logMAR | Standard Deviation 0.16 |
| Topical Prednisolone Acetate Ophthalmic Drops | Loss of Lines in Uncorrected Visual Acuity | 3 months | -0.068 logMAR | Standard Deviation 0.156 |
Secondary
Number of Lines Lost From Best Corrected Visual Acuity
After manifest refraction all units assessed for best corrected distance visual acuity using ETDRS. Number of lines seen was then converted to LogMar score (on a scale of -0.30 to 1.00 where smaller numbers indicate better vision and larger numbers indicate worse vision) to measure changes in Best Corrected Distance Visual Acuity between Baseline and Day 90
Time frame: Baseline through Day 90
Population: All subjects were seen through week 1; three were lost to follow up thereafter.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dexamethasone Ophthalmic Insert 0.4 mg | Number of Lines Lost From Best Corrected Visual Acuity | 0 Score on a scale |
| Topical Prednisolone Acetate Ophthalmic Drops | Number of Lines Lost From Best Corrected Visual Acuity | 0 Score on a scale |
Secondary
Patient Preference Between Groups
As reported by patients choosing one of five options; Strongly preferred insert, preferred insert, no preference, preferred standard drop regimen, strongly preferred standard drop regimen.
Time frame: Day 7, Day 30 and Day 90
Population: All subjects were seen through week 1; three were lost to follow up thereafter.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone Ophthalmic Insert 0.4 mg | Patient Preference Between Groups | Day 30 | 11 Participants |
| Dexamethasone Ophthalmic Insert 0.4 mg | Patient Preference Between Groups | Day 7 | 14 Participants |
| Dexamethasone Ophthalmic Insert 0.4 mg | Patient Preference Between Groups | Day 90 | 9 Participants |
| Topical Prednisolone Acetate Ophthalmic Drops | Patient Preference Between Groups | Day 30 | 3 Participants |
| Topical Prednisolone Acetate Ophthalmic Drops | Patient Preference Between Groups | Day 7 | 2 Participants |
| Topical Prednisolone Acetate Ophthalmic Drops | Patient Preference Between Groups | Day 90 | 3 Participants |
| No Preference | Patient Preference Between Groups | Day 7 | 4 Participants |
| No Preference | Patient Preference Between Groups | Day 90 | 5 Participants |
| No Preference | Patient Preference Between Groups | Day 30 | 3 Participants |
Secondary
Post op Pain Management Per Eye
Count of participants requiring pain management from Day 0 to Day 90.
Time frame: Day 0 to Day 90
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Dexamethasone Ophthalmic Insert 0.4 mg | Post op Pain Management Per Eye | 0 Eyes |
| Topical Prednisolone Acetate Ophthalmic Drops | Post op Pain Management Per Eye | 0 Eyes |