PainNCT00691925
Mitigating Pain Following Refractive Surgery
An observational study of Pain, run by FORSIGHT Vision3 at 1 site in Israel.
Trial summary
Using Contact lens following refractive procedure to reduce pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain
- How many people
- 4 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2008to Dec 2008
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: at least 10 subjects following refractive surgery
Who may be able to join
- Patients who underwent bilateral Refractive surgery for myopic correction.
- Age 18-60.
- Evidence of an epithelial defect.
- Patient complains of significant pain.
- Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits.
Who cannot join
- Any other anterior segment abnormality other than that associated with Refractive surgery.
- Any abnormalities associated with the eye lids.
- Prior laser treatment of the retina.
- Any ophthalmic surgery performed within three (3) months prior to study excluding Refractive surgery.
- Diagnosis of glaucoma.
- Active diabetic retinopathy.
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- Clinically significant inflammation or infection within six (6) months prior to study.
- Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
- Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational material.
- Intolerance or hypersensitivity to topical anesthetics,
- Specifically known intolerance or hypersensitivity to contact lenses.
- A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
- Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contact Lens for Mitigating Pain Following Refractive Procedure
Using Contact lens following refractive procedure to reduce pain.
Read the detailed description
Patients at day 1 following the procedure will be treated with a contact lens and assessed for pain at 1,2,4 hours and 1,3,5 days.
prospective comparative study
- Conditions
- Pain
- Keywords
- refractive surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | bilateral post refractive surgery subject |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- FORSIGHT Vision3
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Verssano, MD, Principal investigator, Sorasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691925
- Sponsor's protocol ID
- 0164
- Status last verified
- Jun 2009
- First submitted
- 4 Jun 2008
- Last updated
- 3 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contact Lens for Mitigating Pain Following Refractive Procedure
- ClinicalTrials.gov ID
- NCT00691925
- Acronym / sponsor ID
- 0164
- Conditions
- Pain
- Keywords
- refractive surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- FORSIGHT Vision3Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 Jun 2008 (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.
Using Contact lens following refractive procedure to reduce pain.
Detailed description
Patients at day 1 following the procedure will be treated with a contact lens and assessed for pain at 1,2,4 hours and 1,3,5 days.
prospective comparative study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –bilateral post refractive surgery subject |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- at least 10 subjects following refractive surgery
Key inclusion criteria (5 listed)
- Patients who underwent bilateral Refractive surgery for myopic correction.
- Age 18-60.
- Evidence of an epithelial defect.
- Patient complains of significant pain.
- Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits.
Key exclusion criteria (13 listed)
- Any other anterior segment abnormality other than that associated with Refractive surgery.
- Any abnormalities associated with the eye lids.
- Prior laser treatment of the retina.
- Any ophthalmic surgery performed within three (3) months prior to study excluding Refractive surgery.
- Diagnosis of glaucoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 3 Jun 2009.
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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.
David Verssano, MD principal investigator
Sorasky Medical Center
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 FORSIGHT Vision3 at 1 site in Israel.
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 13 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 3 Jun 2009. 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 Israel. 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.
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 3 Jun 2009.