Keratomileusis, Laser In SituPhase 4NCT00366808
Mechanical vs. Alcohol Separation of the Corneal Epithelium During Surface Ablation Refractive Procedures
A Phase 4 study testing LASIK surgery in people with Keratomileusis, Laser In Situ, run by Medical University of South Carolina at 1 site in United States.
Trial summary
A recent survey of trends among the members of the American Society of Cataract and Refractive Surgery determined that laser in situ keratomileusis (LASIK) is the leading surgical procedure for photorefractive corrections ranging from -0 to 3 diopters (D).1 The same survey, however, showed a clear trend of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratomileusis, Laser In Situ
- What is being tested?
- LASIK surgery
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Aug 2007
- 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
- Subject must be a candidate for surface ablation procedures in both eyes.
- ≥ 18 years of age or older.
- Myopia ≤ -6.00 D.
- Astigmatism ≤ - 3.00 D.
- Manifest refraction spherical equivalent (MRSE) of -6.00 D.
- Capable of wearing a bandage contact lens.
- Willing and able to comply with scheduled visits and other study procedures.
Who cannot join
- History of ocular pathology.
- Very large pupils (greater than 8mm diameter, infrared measurement).
- Thin corneas (preoperatively calculated minimal residual bed < 250 um).
- If patient fit into the group of the usual exclusionary criteria (e.g. irregular astigmatism, asymmetric astigmatism, unstable refraction - most of these patients would not typically be considered LASIK candidates under normal circumstances).
- History of previous refractive surgery.
- Corneal irregularities potentially affecting visual acuity: keratoconus, corneal dystrophy, corneal opacities.
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- Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
- Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.
- Use of any systemic or topical drug known to interfere with visual performance.
- Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control
- Inability or unwillingness of subjects to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magill Laser Center, Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
A recent survey of trends among the members of the American Society of Cataract and Refractive Surgery determined that laser in situ keratomileusis (LASIK) is the leading surgical procedure for photorefractive corrections ranging from -0 to 3 diopters (D).1 The same survey, however, showed a clear trend of participating refractive surgeons toward surface ablation. Photorefractive keratectomy (PRK) was the first refractive surgery procedure approved and performed using the excimer laser. Several techniques of epithelial debridement have been tried with PRK-type surgery including mechanical debridement, laser transepithelial ablation, a rotating brush, and alcohol debridement.
The Amadeus II microkeratome (Advanced Medical Optics Inc, Irvine, CA, USA) used for the creation of a LASIK flap has an upgradeable platform that will allow the user to perform mechanical separation of the corneal epithelium before photorefractive treatments. With the use of this device, the corneal epithelium can be separated from the underlying stroma without previous preparation of the corneal surface with alcohol. The separated epithelial sheet can either be removed or replaced on the operated cornea after photoablation. This surgical procedure, which has been called Epi-LASIK, represents an advanced alternative surface ablation photorefractive procedure for the correction of ametropia. The purpose of this study is to evaluate the clinical visual outcomes, healing rates, and patient satisfaction when performing surface ablation procedures using mechanical vs. alcohol separation of the epithelium.
- Conditions
- Keratomileusis, Laser In Situ
- Being tested
- LASIK surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASIK surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startFeb 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratomileusis, Laser In SituStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Kerry Solomon, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366808
- Sponsor's protocol ID
- MRC-06-003
- Status last verified
- Jul 2006
- First submitted
- 17 Aug 2006
- Last updated
- 14 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical vs. Alcohol Separation of the Corneal Epithelium During Surface Ablation Refractive Procedures
- ClinicalTrials.gov ID
- NCT00366808
- Acronym / sponsor ID
- MRC-06-003
- Conditions
- Keratomileusis, Laser In Situ
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 21 Aug 2006 (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.
A recent survey of trends among the members of the American Society of Cataract and Refractive Surgery determined that laser in situ keratomileusis (LASIK) is the leading surgical procedure for photorefractive corrections ranging from -0 to 3 diopters (D).1 The same survey, however, showed a clear trend of participating refractive surgeons toward surface ablation. Photorefractive keratectomy (PRK) was the first refractive surgery procedure approved and performed using the excimer laser. Several techniques of epithelial debridement have been tried with PRK-type surgery including mechanical debridement, laser transepithelial ablation, a rotating brush, and alcohol debridement.
The Amadeus II microkeratome (Advanced Medical Optics Inc, Irvine, CA, USA) used for the creation of a LASIK flap has an upgradeable platform that will allow the user to perform mechanical separation of the corneal epithelium before photorefractive treatments. With the use of this device, the corneal epithelium can be separated from the underlying stroma without previous preparation of the corneal surface with alcohol. The separated epithelial sheet can either be removed or replaced on the operated cornea after photoablation. This surgical procedure, which has been called Epi-LASIK, represents an advanced alternative surface ablation photorefractive procedure for the correction of ametropia. The purpose of this study is to evaluate the clinical visual outcomes, healing rates, and patient satisfaction when performing surface ablation procedures using mechanical vs. alcohol separation of the epithelium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must be a candidate for surface ablation procedures in both eyes.
- ≥ 18 years of age or older.
- Myopia ≤ -6.00 D.
- Astigmatism ≤ - 3.00 D.
- Manifest refraction spherical equivalent (MRSE) of -6.00 D.
Key exclusion criteria (11 listed)
- History of ocular pathology.
- Very large pupils (greater than 8mm diameter, infrared measurement).
- Thin corneas (preoperatively calculated minimal residual bed < 250 um).
- If patient fit into the group of the usual exclusionary criteria (e.g. irregular astigmatism, asymmetric astigmatism, unstable refraction - most of these patients would not typically be considered LASIK candidates under normal circumstances).
- History of previous refractive surgery.
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 |
|---|---|---|
| LASIK surgery | Procedure or surgery | – |
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 14 Jun 2018.
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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.
Kerry Solomon, MD principal investigator
Medical University of South Carolina
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 LASIK surgery in people with Keratomileusis, Laser In Situ, run by Medical University of South Carolina 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 7 inclusion and 11 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 14 Jun 2018. 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?
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 14 Jun 2018.