MyopiaPhase 4NCT04283331
Anesthetic Impregnated Bandage Soft Contact Lens (BSCL) in Pain Management After Photorefractive Keratectomy (PRK)
A Phase 4 study testing Proparacaine Ophthalmic in people with Myopia and Hypermetropia, run by Beeran Meghpara, MD at 1 site in United States.
Trial summary
Compared to laser-assisted in situ keratomileusis (LASIK), Photorefractive Keratectomy (PRK) is associated with more discomfort and requires more downtime. However, it is oftentimes considered the preferred method of refractive surgery for patients with dry eye syndrome, high refractive errors, thin corneas, or those… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia, Hypermetropia, Refractive Errors
- What is being tested?
- Proparacaine Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 31 Dec 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All eyes approved for photorefractive keratectomy with Dr. Beeran Meghpara or Dr. Christopher Rapuano, with or without the assistance of residents.
Who cannot join
- Patients undergoing unilateral procedure.
- Eyes that experience complication during the photorefractive keratectomy procedure
- Patients who are pregnant or breast feeding
- Patients under 18 years of age
- Patients with a history of eye surgery or trauma and those with irregular astigmatism, keratoconus, or any other type of corneal disorder, pregnancy, diabetic retinopathy, or glaucoma.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Wills Eye Hospital
Philadelphia, Pennsylvania, 19123
Beeran Meghpara, MD, 215-928-3180, bmeghpara@willseye.org
About this study
Official title: Efficacy and Safety of Anesthetic Impregnated Bandage Soft Contact Lens (BSCL) in Pain Management After Photorefractive Keratectomy (PRK).
Compared to laser-assisted in situ keratomileusis (LASIK), Photorefractive Keratectomy (PRK) is associated with more discomfort and requires more downtime. However, it is oftentimes considered the preferred method of refractive surgery for patients with dry eye syndrome, high refractive errors, thin corneas, or those with more active lifestyles who may be more prone to dislodging their LASIK flaps. We hypothesize that the use of bandage contact lenses soaked in proparacaine will decrease pain levels compared to solely the use of bandage contact lenses after PRK.
Read the detailed description
Photorefractive keratectomy (PRK) is a popular method for the correction of refractive errors. Compared to laser-assisted in situ keratomileusis (LASIK), PRK is often associated with more discomfort and requires more downtime. However, it is oftentimes considered the preferred method of refractive surgery for patients with dry eye syndrome, high refractive errors, thin corneas, or those with more active lifestyles who may be more prone to dislodging their LASIK flaps. It can also avoid other complications associated with LASIK including striae, folds, diffuse lamellar keratitis, and epithelial ingrowth. As a result, improved management of post-operative pain in patients undergoing PRK is critical in order encourage utilization and patient preference of this procedure.
The current standard of care for pain management after PRK is the use of a bandage soft contact lens (BSCL). BSCLs may speed reepithelialization and function as an adjunct for pain control.
Using a BSCL soaked in proparacaine has not yet been studied as a pain management method after PRK. Our hypothesis is that combining these two methods will result in greater pain reduction than using a BSCL alone, which is the current standard of care. Furthermore, soaking the BSCL in anesthetics will reduce the chance that patients can abuse anesthetic medication postoperatively, which is the concern when patients are sent home with anesthetic drops as is noted in several prior studies.
This study aims to explore the potential of an anesthetic soaked bandage soft contact lens in reducing pain levels compared to a bandage soft contact lens alone after PRK.
Study Goals:
- To assess the perception of pain following photorefractive keratectomy with the utilization of an anesthetic soaked bandage soft contact lens versus control (BSCL only) using the Visual Analog Pain Scale.
- To assess the effect of an anesthetic soaked bandage soft contact lens on re-epithelialization following photorefractive keratectomy versus control. This will be assessed on post-operative day 5 as whether there is a persistent epithelial defect or not, a binary outcome.
- Conditions
- Myopia, Hypermetropia, Refractive Errors, Astigmatism
- Being tested
- Proparacaine Ophthalmic
- Keywords
- refractive surgery; PRK; LASIK
- Medical subject headings
- Myopia, Hyperopia, Refractive Errors, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proparacaine OphthalmicDrug
Also called Proparacaine, proparacaine hydrochloride 0.5%
Each subject will have one eye randomized to receive a bandage contact lens soaked in anesthetic solution (proparacaine hydrochloride 0.5%) and the following eye will serve as a control and receive a bandage soft contact lens soaked in balanced salt solution, which is the current standard of care for PRK.
| Study group | Role | What they receive |
|---|---|---|
| Bandage Contact Lens + Proparacaine | Experimental | The eye that receives a bandage contact lens soaked in proparacaine. Receives: Drug: Proparacaine Ophthalmic |
| Bandage Contact Lens WITHOUT Proparacaine | No intervention | The eye that receives a bandage contact lens (standard of care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily pain score at post-operative day 0 through post-operative day 5
Primary Outcome Measure is pain score at post-operative day 0 THROUGH post-operative day 5. Patients will be asked to fill out their score daily.
The Wong-Baker Faces pain scale will be used to measure pain. This is a self-report measure of pain consisting of a series of faces with expressions of increasing distress. Each face is also given a numerical rating from 0 to 5, zero representing no pain and 5 representing worst pain.
Measured: 5 days
Secondary outcomes (2)
Complete re-epithelialization at post-operative day 5
A binary outcome (yes/no) of whether the corneal epithelium has completely healed by post-operative day 5.
Measured: 5 days
Final refractive outcome at postoperative month 3
Snellen visual acuity, both without correction and best corrected with a manifest refraction.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 Jun 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beeran Meghpara, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Beeran Meghpara, MD, Wills Eye
- Investigators
- Beeran Meghpara, MD, Principal investigator, Wills Eye Hospital at TJUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283331
- Sponsor's protocol ID
- 19-871
- Status last verified
- Oct 2021
- First submitted
- 16 Feb 2020
- Last updated
- 6 Oct 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Anesthetic Impregnated Bandage Soft Contact Lens (BSCL) in Pain Management After Photorefractive Keratectomy (PRK).
- ClinicalTrials.gov ID
- NCT04283331
- Acronym / sponsor ID
- 19-871
- Conditions
- Myopia, Hypermetropia, Refractive Errors, Astigmatism
- Keywords
- refractive surgery; PRK; LASIK
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beeran Meghpara, MDUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 25 Feb 2020 (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.
Compared to laser-assisted in situ keratomileusis (LASIK), Photorefractive Keratectomy (PRK) is associated with more discomfort and requires more downtime. However, it is oftentimes considered the preferred method of refractive surgery for patients with dry eye syndrome, high refractive errors, thin corneas, or those with more active lifestyles who may be more prone to dislodging their LASIK flaps. We hypothesize that the use of bandage contact lenses soaked in proparacaine will decrease pain levels compared to solely the use of bandage contact lenses after PRK.
Detailed description
Photorefractive keratectomy (PRK) is a popular method for the correction of refractive errors. Compared to laser-assisted in situ keratomileusis (LASIK), PRK is often associated with more discomfort and requires more downtime. However, it is oftentimes considered the preferred method of refractive surgery for patients with dry eye syndrome, high refractive errors, thin corneas, or those with more active lifestyles who may be more prone to dislodging their LASIK flaps. It can also avoid other complications associated with LASIK including striae, folds, diffuse lamellar keratitis, and epithelial ingrowth. As a result, improved management of post-operative pain in patients undergoing PRK is critical in order encourage utilization and patient preference of this procedure.
The current standard of care for pain management after PRK is the use of a bandage soft contact lens (BSCL). BSCLs may speed reepithelialization and function as an adjunct for pain control.
Using a BSCL soaked in proparacaine has not yet been studied as a pain management method after PRK. Our hypothesis is that combining these two methods will result in greater pain reduction than using a BSCL alone, which is the current standard of care. Furthermore, soaking the BSCL in anesthetics will reduce the chance that patients can abuse anesthetic medication postoperatively, which is the concern when patients are sent home with anesthetic drops as is noted in several prior studies.
This study aims to explore the potential of an anesthetic soaked bandage soft contact lens in reducing pain levels compared to a bandage soft contact lens alone after PRK.
Study Goals:
- To assess the perception of pain following photorefractive keratectomy with the utilization of an anesthetic soaked bandage soft contact lens versus control (BSCL only) using the Visual Analog Pain Scale.
- To assess the effect of an anesthetic soaked bandage soft contact lens on re-epithelialization following photorefractive keratectomy versus control. This will be assessed on post-operative day 5 as whether there is a persistent epithelial defect or not, a binary outcome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bandage Contact Lens + Proparacaine | Experimental | Drug: Proparacaine OphthalmicThe eye that receives a bandage contact lens soaked in proparacaine. |
| Bandage Contact Lens WITHOUT Proparacaine | No intervention | –The eye that receives a bandage contact lens (standard of care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All eyes approved for photorefractive keratectomy with Dr. Beeran Meghpara or Dr. Christopher Rapuano, with or without the assistance of residents.
Key exclusion criteria (5 listed)
- Patients undergoing unilateral procedure.
- Eyes that experience complication during the photorefractive keratectomy procedure
- Patients who are pregnant or breast feeding
- Patients under 18 years of age
- Patients with a history of eye surgery or trauma and those with irregular astigmatism, keratoconus, or any other type of corneal disorder, pregnancy, diabetic retinopathy, or glaucoma.
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 |
|---|---|---|
| Proparacaine OphthalmicAlso: Proparacaine, proparacaine hydrochloride 0.5%Each subject will have one eye randomized to receive a bandage contact lens soaked in anesthetic solution (proparacaine hydrochloride 0.5%) and the following eye will serve as a control and receive a bandage soft contact lens soaked in balanced salt solution, which is the current standard of care for PRK. | Drug | Bandage Contact Lens + Proparacaine |
Primary outcome
Daily pain score at post-operative day 0 through post-operative day 5
Time frame: 5 days
Primary Outcome Measure is pain score at post-operative day 0 THROUGH post-operative day 5. Patients will be asked to fill out their score daily. The Wong-Baker Faces pain scale will be used to measure pain. This is a self-report measure of pain consisting of a series of faces with expressions of increasing distress. Each face is also given a numerical rating from 0 to 5, zero representing no pain and 5 representing worst pain.
2 secondary outcomes
Complete re-epithelialization at post-operative day 5
Time frame: 5 days
Final refractive outcome at postoperative month 3
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
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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.
Beeran Meghpara, MD principal investigator
Wills Eye Hospital at TJUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Proparacaine Ophthalmic in people with Myopia and Hypermetropia, run by Beeran Meghpara, MD 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 5 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: status not confirmed, as of the sponsor's last update on 6 Oct 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beeran Meghpara, MD (2159283180, bmeghpara@willseye.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily pain score at post-operative day 0 through post-operative day 5 (time frame: 5 days). 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 6 Oct 2021.