Corneal DiseasesNCT00491439
Using in Vivo Confocal Microscope to Evaluate the Corneal Wound Healing After Various Ocular Surgeries
An observational study of Corneal Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Although epi-keratome laser-assisted in situ keratomileusis (Epi-LASIK), penetrating keratoplasty and pars plana vitrectomy with corneal epithelial debridement for diabetic retinopathy are surgeries commonly performed, the time-sequential, in vivo microscopic wound healing process is not fully understood. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corneal Diseases
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2007to Sep 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients receiving Epi-LASIK, penetrating keratoplasty and pars plana vitrectioy with corneal epithelial debridement for diabetic retinopathy
Who may be able to join
- patients receiving various ocular surgeries
- no previous ocular surgery
- tear break up time longer than 10 seconds
- Shirmer test II larger than 5 mm
- no presurgical corneal disease confirmed by slit lamp and in vivo confocal
- no limbus defect
- proliferative retinopathy underwent vitrectomy combining corneal epithelial scrating
Who cannot join
- can not complete follow up
- ineligible for ocular surgery
- eyelid closure incomplete
- glaucoma
- corneal defect or oculoneuropathy not caused by diabetes
- severe dry eye disease
- limbus defect
- pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of in Vivo Confocal Microscope to Evaluate the Corneal Wound Healing After Various Ocular Surgeries
Although epi-keratome laser-assisted in situ keratomileusis (Epi-LASIK), penetrating keratoplasty and pars plana vitrectomy with corneal epithelial debridement for diabetic retinopathy are surgeries commonly performed, the time-sequential, in vivo microscopic wound healing process is not fully understood. The purpose of this study is to study the healing of corneal wounds after Epi-LASIK, penetrating keratoplasty and pars plana vitrectomy with corneal epithelial debridement for diabetic retinopathy by in vivo confocal microscopy, an easily performed and non-invasive procedure. We plan to enroll 40 eyes of 40 patients in each of these three surgeries. In Epi-LASIK, slit-lamp biomicroscopy, in vivo confocal microscopy, and visual acuity are recorded before and 1, 3, and 7 days after surgery. The eyes are examined weekly in the first month and at 3 and 6 months. For penetrating keratoplasty and pars plana vitrectomy with corneal epithelial debridement, slit-lamp biomicroscopy, in vivo confocal microscopy, and visual acuity are recorded before and weekly in the first month after surgeries and at 3 and 6 months. Selected images of the corneal basal/apical surface epithelia, stromal reactions and corneal endothelial conditions by in vivo confocal microscopy are evaluated qualitatively for the cellular morphology and density.
Read the detailed description
Although epi-keratome laser-assisted in situ keratomileusis (Epi-LASIK), penetrating keratoplasty and pars plana vitrectomy with corneal epithelial debridement for diabetic retinopathy are surgeries commonly performed, the time-sequential, in vivo microscopic wound healing process is not fully understood. The purpose of this study is to study the healing of corneal wounds after Epi-LASIK, penetrating keratoplasty and pars plana vitrectomy with corneal epithelial debridement for diabetic retinopathy by in vivo confocal microscopy, an easily performed and non-invasive procedure. We plan to enroll 40 eyes of 40 patients in each of these three surgeries. In Epi-LASIK, slit-lamp biomicroscopy, in vivo confocal microscopy, and visual acuity are recorded before and 1, 3, and 7 days after surgery. The eyes are examined weekly in the first month and at 3 and 6 months. For penetrating keratoplasty and pars plana vitrectomy with corneal epithelial debridement, slit-lamp biomicroscopy, in vivo confocal microscopy, and visual acuity are recorded before and weekly in the first month after surgeries and at 3 and 6 months. Selected images of the corneal basal/apical surface epithelia, stromal reactions and corneal endothelial conditions by in vivo confocal microscopy are evaluated qualitatively for the cellular morphology and density.
- Conditions
- Corneal Diseases
- Keywords
- in vivo confocal microscopy, vitrectomy, corneal transplantation, Epi-LASIK, wound healing
- Medical subject headings
- Corneal Diseases
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 |
|---|---|---|
| Corneal wounds after Epi-LASIK | Corneal wounds after Epi-LASIK | |
| penetrating keratoplasty | Corneal wound after penetrating keratoplasty | |
| corneal epithelial debridement | Corneal wound after pars plana vitrectioy with corneal epithelial debridement for diabetic retinopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cellular morphology and density
Measured: before surgery and 1, 3, and 7 days after surgeryfirst month and at 3 and 6 months
Secondary outcomes (2)
corneal basal/apical surface epithelia, stromal reactions and corneal endothelial conditions
Measured: before and 1, 3, and 7 days after surgery, first month and at 3 and 6 months
visual acuity
Measured: before and 1, 3, and 7 days after surgery, first month and at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startApr 2007
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corneal DiseasesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Fung-Rong Hu, MD, Principal investigator, Department of Ophthalmology, National Taiwan Universtiy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491439
- Sponsor's protocol ID
- 200702038R
- Status last verified
- Nov 2010
- First submitted
- 23 Jun 2007
- Last updated
- 3 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Chen WL, Shen EP, Hsieh YT, Yeh PT, Wang TJ, Hu FR. Comparison of in vivo confocal microscopic findings between epi-LASIK procedures with different management of the epithelial flaps. Invest Ophthalmol Vis Sci. 2011 Jun 1;52(6):3640-7. doi: 10.1167/iovs.10-6390.
PubMed 21357404
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of in Vivo Confocal Microscope to Evaluate the Corneal Wound Healing After Various Ocular Surgeries
- ClinicalTrials.gov ID
- NCT00491439
- Acronym / sponsor ID
- 200702038R
- Conditions
- Corneal Diseases
- Keywords
- in vivo confocal microscopy, vitrectomy, corneal transplantation, Epi-LASIK, wound healing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2007
- Study completion
- Sep 2010 (actual)
- First posted
- 26 Jun 2007 (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.
Although epi-keratome laser-assisted in situ keratomileusis (Epi-LASIK), penetrating keratoplasty and pars plana vitrectomy with corneal epithelial debridement for diabetic retinopathy are surgeries commonly performed, the time-sequential, in vivo microscopic wound healing process is not fully understood. The purpose of this study is to study the healing of corneal wounds after Epi-LASIK, penetrating keratoplasty and pars plana vitrectomy with corneal epithelial debridement for diabetic retinopathy by in vivo confocal microscopy, an easily performed and non-invasive procedure. We plan to enroll 40 eyes of 40 patients in each of these three surgeries. In Epi-LASIK, slit-lamp biomicroscopy, in vivo confocal microscopy, and visual acuity are recorded before and 1, 3, and 7 days after surgery. The eyes are examined weekly in the first month and at 3 and 6 months. For penetrating keratoplasty and pars plana vitrectomy with corneal epithelial debridement, slit-lamp biomicroscopy, in vivo confocal microscopy, and visual acuity are recorded before and weekly in the first month after surgeries and at 3 and 6 months. Selected images of the corneal basal/apical surface epithelia, stromal reactions and corneal endothelial conditions by in vivo confocal microscopy are evaluated qualitatively for the cellular morphology and density.
Detailed description
Although epi-keratome laser-assisted in situ keratomileusis (Epi-LASIK), penetrating keratoplasty and pars plana vitrectomy with corneal epithelial debridement for diabetic retinopathy are surgeries commonly performed, the time-sequential, in vivo microscopic wound healing process is not fully understood. The purpose of this study is to study the healing of corneal wounds after Epi-LASIK, penetrating keratoplasty and pars plana vitrectomy with corneal epithelial debridement for diabetic retinopathy by in vivo confocal microscopy, an easily performed and non-invasive procedure. We plan to enroll 40 eyes of 40 patients in each of these three surgeries. In Epi-LASIK, slit-lamp biomicroscopy, in vivo confocal microscopy, and visual acuity are recorded before and 1, 3, and 7 days after surgery. The eyes are examined weekly in the first month and at 3 and 6 months. For penetrating keratoplasty and pars plana vitrectomy with corneal epithelial debridement, slit-lamp biomicroscopy, in vivo confocal microscopy, and visual acuity are recorded before and weekly in the first month after surgeries and at 3 and 6 months. Selected images of the corneal basal/apical surface epithelia, stromal reactions and corneal endothelial conditions by in vivo confocal microscopy are evaluated qualitatively for the cellular morphology and density.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Corneal wounds after Epi-LASIK | – | –Corneal wounds after Epi-LASIK |
| penetrating keratoplasty | – | –Corneal wound after penetrating keratoplasty |
| corneal epithelial debridement | – | –Corneal wound after pars plana vitrectioy with corneal epithelial debridement for diabetic retinopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving Epi-LASIK, penetrating keratoplasty and pars plana vitrectioy with corneal epithelial debridement for diabetic retinopathy
Key inclusion criteria (7 listed)
- patients receiving various ocular surgeries
- no previous ocular surgery
- tear break up time longer than 10 seconds
- Shirmer test II larger than 5 mm
- no presurgical corneal disease confirmed by slit lamp and in vivo confocal
Key exclusion criteria (8 listed)
- can not complete follow up
- ineligible for ocular surgery
- eyelid closure incomplete
- glaucoma
- corneal defect or oculoneuropathy not caused by diabetes
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
cellular morphology and density
Time frame: before surgery and 1, 3, and 7 days after surgeryfirst month and at 3 and 6 months
2 secondary outcomes
corneal basal/apical surface epithelia, stromal reactions and corneal endothelial conditions
Time frame: before and 1, 3, and 7 days after surgery, first month and at 3 and 6 months
visual acuity
Time frame: before and 1, 3, and 7 days after surgery, first month and at 3 and 6 months
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 Apr 2012.
- Derived from this study: PubMed 21357404Chen WL, Shen EP, Hsieh YT, Yeh PT, Wang TJ, Hu FR. Comparison of in vivo confocal microscopic findings between epi-LASIK procedures with different management of the epithelial flaps. Invest Ophthalmol Vis Sci. 2011 Jun 1;52(6):3640-7. doi: 10.1167/iovs.10-6390.
Related trials for Corneal Diseases
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Not yet recruiting
A Single-Center Clinical Study Evaluating the Efficacy and Safety of Allogeneic Natural Killer (NK) Cell Transplantation for Mooren's Ulcer
Cornea Disease
Not yet recruitingObservational study
Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
Myopia
Recruiting
4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800
Corneal Diseases, Retinal Diseases
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.
Fung-Rong Hu, MD principal investigator
Department of Ophthalmology, National Taiwan Universtiy Hospital
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 Corneal Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
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 8 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 Apr 2012. 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 Taiwan. 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.
What does the primary outcome measure?
cellular morphology and density (time frame: before surgery and 1, 3, and 7 days after surgeryfirst month and at 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00491439, which also lists 1 linked publication.
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 Apr 2012.