Pain After Photorefractive KeratectomyPhase 4NCT01177514
The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy
A Phase 4 study testing Gabapentin and Sugar pill in people with Pain After Photorefractive Keratectomy, run by Codet Vision Institute at 1 site in Mexico.
Trial summary
The primary aims of this study are to determine if treatment with Gabapentin taken systemically (oral tablets) in patients who have photorefractive keratectomy (PRK) surgical treatments reduces post surgical neuropathic pain and discomfort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain After Photorefractive Keratectomy
- What is being tested?
- Gabapentin and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2010to Nov 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be at least 18 years of age
- Subjects must not have any corneal disease or degeneration
- Subjects must be candidates for LASIK or PRK refractive surgery
Who cannot join
- History of topical ocular medications within 4 weeks prior to enrollment
- History of conjunctivitis or ocular inflammation within 4 weeks prior to enrollment
- History of a previous refractive surgery
- History of previous diagnosis of corneal disease, degeneration, or glaucoma
- History of autoimmune disease
- History of oral anti-histamines currently or within 1 week of study enrollment
Show all 12Show fewer
- History of systemic anti-inflammatory or pain medication currently or within 4 weeks of study enrollment
- Use of oral diuretics or betablocker currently or within 1 week of study enrollment
- Current diagnosis of dry eye
- Patients whose Best corrected vision is less than 20/20
- Patients whose target post operative refraction is not plano
- Pregnant and lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy A Prospective, Randomized, Double Blinded, Placebo Controlled Study
The primary aims of this study are to determine if treatment with Gabapentin taken systemically (oral tablets) in patients who have photorefractive keratectomy (PRK) surgical treatments reduces post surgical neuropathic pain and discomfort. The investigators main Hypothesis is that gabapentin given prior to and after refractive surgery prevents central sensitization and local allodynia.
- Conditions
- Pain After Photorefractive Keratectomy
- Being tested
- Gabapentin, Sugar pill
- Keywords
- Refractive surgery, PRK, PAIN, Gabapentin
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Gabapentin PO. (300MG) 1 capsule the night before surgery, q12hrs the day of surgery and q8hrs for the firt 3 postoperative days.
Sugar pillDrug
Sugar pill. One capsule given the night before surgery, q12hrs on the day of surgery and q8hrs for the first 3 postoperative days.
| Study group | Role | What they receive |
|---|---|---|
| GABAPENTIN | Experimental | Group of patients treated with oral gabapentin Receives: Drug: Gabapentin |
| PLACEBO | Placebo comparator | Group given the placebo capsules Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at moment of examination
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded
Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Measured: 24 hours postoperatively
Average pain for the previous 24 hour period,
Numerical visual scale questionnaire, a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded
Measured: assesed at 24 hours
Maximum pain intensity for the previous 24 hour period
In a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded.
Measured: Assesed at 24 hours postoperatively
Pain at moment of examination
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded
Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Measured: 48 hours postoperatively
pain on examination
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded
Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Measured: 72 hours postoperatively
pain on examination
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded
Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Measured: 96 hours ostoiperatively
Pain at moment of examination
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded
Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Measured: postoperative day 7
Average pain for the previous 24 hour period
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded
Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Measured: Assesed at 48 hours
Average pain during the previous 24 hour period
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded
Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Measured: Assesed at 72 hours postoperatively
Average pain for the last 24 hours period
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded
Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Measured: Assesed at 96 hours postoperatively
Average pain since last examination
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded
Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Measured: Assesed on postopertive day 7
Maximum pain intensity for the previous 24 hour period
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded
Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Measured: Assesed at 48 hours postoperatively
Maximum pain intensity for the previous 24 hour period
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded
Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Measured: Assesed at 72 hours postoperatively
Maximum pain intensity for the last 24 hour period
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded
Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Measured: Assesed at 96 hours postoperatively
Maximum pain intensity since the last examination
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded
Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Measured: Assesed on the 7th postoperative day
Secondary outcomes (10)
Time required for complete healing
Slit lamp observation of the epithelial defect and time until removal of contact lens.
Measured: Evaluated each day until complete healing
Visual acuity
Snellen Chart
Measured: every day until complete healing and at the 7th day postop
Foreign body sensation
Numerical visual scale, In a scale from 0-10 where 0 is the least amount of foreign body sensation and 10 being the most.
Measured: Every 24 hours until complete healing and at the 7th day postop
Light sensitivity
Numerical visual scale, in a scale from 0-10 where 0 is the least amount of light sensitibity and 10 being the most.
Measured: Every 24 hours until complete healing and at the 7th day postop
Tearing and watery eyes
Numerical visual scale questionaire, In a scale from 0-10 where 0 is the least amount of tearing and 10 being the most.
Measured: Every 24 hours until complete healing and at the 7th day postop
Eye discomfort
Numerical visual scale questionnaire, In a scale from 0-10 where 0 is the least amount of discomfort and 10 being the most.
Measured: Every 24 hours until complete healing and at the 7th day postop
Dizziness
Numerical visual scale, scale from 0-10 where 0 is the least dizzy and 10 being the most.
Measured: Every 24 hours until complete healling and at the 7th day postop
lethargy
Numerical visual scale, In a scale from 0-10 where 0 is the least lethargic and 10 is the most.
Measured: Every 24 hours until complete healing and at the 7th day postop
Headache
Numerical visual scale, In a scale from 0-10 where 0 is the least amount of headache and 10 being the most severe headache felt.
Measured: Every 24 hours until complete healing and at the 7th day postop
Gastro-intestinal symptoms
Numerical visual scale, In a scale from 0-10 where 0 is the least amount of symptoms and 10 being the most symptoms.
Measured: Every 24 hours until complete healing and at the 7th day postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain After Photorefractive KeratectomyStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codet Vision Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALEJANDRO LICHTINGER, Codet Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177514
- Sponsor's protocol ID
- GABA1
- Status last verified
- Jul 2015
- First submitted
- 23 Apr 2010
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy A Prospective, Randomized, Double Blinded, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT01177514
- Acronym / sponsor ID
- GABA1
- Conditions
- Pain After Photorefractive Keratectomy
- Keywords
- Refractive surgery, PRK, PAIN, Gabapentin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Codet Vision InstituteUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Aug 2010 (estimated)
- 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 primary aims of this study are to determine if treatment with Gabapentin taken systemically (oral tablets) in patients who have photorefractive keratectomy (PRK) surgical treatments reduces post surgical neuropathic pain and discomfort. The investigators main Hypothesis is that gabapentin given prior to and after refractive surgery prevents central sensitization and local allodynia.
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 |
|---|---|---|
| GABAPENTIN | Experimental | Drug: GabapentinGroup of patients treated with oral gabapentin |
| PLACEBO | Placebo comparator | Drug: Sugar pillGroup given the placebo capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must be at least 18 years of age
- Subjects must not have any corneal disease or degeneration
- Subjects must be candidates for LASIK or PRK refractive surgery
Key exclusion criteria (12 listed)
- History of topical ocular medications within 4 weeks prior to enrollment
- History of conjunctivitis or ocular inflammation within 4 weeks prior to enrollment
- History of a previous refractive surgery
- History of previous diagnosis of corneal disease, degeneration, or glaucoma
- History of autoimmune disease
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 |
|---|---|---|
| GabapentinGabapentin PO. (300MG) 1 capsule the night before surgery, q12hrs the day of surgery and q8hrs for the firt 3 postoperative days. | Drug | GABAPENTIN |
| Sugar pillSugar pill. One capsule given the night before surgery, q12hrs on the day of surgery and q8hrs for the first 3 postoperative days. | Drug | PLACEBO |
Primary outcome
Pain at moment of examination
Time frame: 24 hours postoperatively
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Average pain for the previous 24 hour period,
Time frame: assesed at 24 hours
Numerical visual scale questionnaire, a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded
Maximum pain intensity for the previous 24 hour period
Time frame: Assesed at 24 hours postoperatively
In a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded.
Pain at moment of examination
Time frame: 48 hours postoperatively
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
pain on examination
Time frame: 72 hours postoperatively
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
pain on examination
Time frame: 96 hours ostoiperatively
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Pain at moment of examination
Time frame: postoperative day 7
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Average pain for the previous 24 hour period
Time frame: Assesed at 48 hours
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Average pain during the previous 24 hour period
Time frame: Assesed at 72 hours postoperatively
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Average pain for the last 24 hours period
Time frame: Assesed at 96 hours postoperatively
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Average pain since last examination
Time frame: Assesed on postopertive day 7
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Maximum pain intensity for the previous 24 hour period
Time frame: Assesed at 48 hours postoperatively
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Maximum pain intensity for the previous 24 hour period
Time frame: Assesed at 72 hours postoperatively
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Maximum pain intensity for the last 24 hour period
Time frame: Assesed at 96 hours postoperatively
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Maximum pain intensity since the last examination
Time frame: Assesed on the 7th postoperative day
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
10 secondary outcomes
Time required for complete healing
Time frame: Evaluated each day until complete healing
Visual acuity
Time frame: every day until complete healing and at the 7th day postop
Foreign body sensation
Time frame: Every 24 hours until complete healing and at the 7th day postop
Light sensitivity
Time frame: Every 24 hours until complete healing and at the 7th day postop
Tearing and watery eyes
Time frame: Every 24 hours until complete healing and at the 7th day postop
Eye discomfort
Time frame: Every 24 hours until complete healing and at the 7th day postop
Dizziness
Time frame: Every 24 hours until complete healling and at the 7th day postop
lethargy
Time frame: Every 24 hours until complete healing and at the 7th day postop
Headache
Time frame: Every 24 hours until complete healing and at the 7th day postop
Gastro-intestinal symptoms
Time frame: Every 24 hours until complete healing and at the 7th day postop
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 29 Jul 2015.
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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 Phase 4 study testing Gabapentin and Sugar pill in people with Pain After Photorefractive Keratectomy, run by Codet Vision Institute at 1 site in Mexico.
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 3 inclusion and 12 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 29 Jul 2015. 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 Mexico. 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. Some participants in this study may receive a placebo. 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?
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?
Pain at moment of examination (time frame: 24 hours postoperatively). The study lists 15 primary outcomes in all. 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 29 Jul 2015.