KeratitisNCT00492245
Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities
A study testing PTK with mitomycin in Adenoviral Opacities in people with Keratitis and Corneal Opacity, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The present study was designed to evaluate the treatment of adenoviral corneal opacities with PTK and mitomycin C. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Keratitis, Corneal Opacity
- What is being tested?
- PTK with mitomycin in Adenoviral Opacities
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2006to Dec 2008
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- visual acuity worse than 20/40, caused by central subepithelial fibrosis
Who cannot join
- pregnancy, age less than 18 years-old or more than 80 years-old.
- diabetes, autoimmune diseases, corneal thickness less tha 400 micron.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phototherapeutic Keratectomy With Mitomycin C in Adenoviral Infiltrates
The present study was designed to evaluate the treatment of adenoviral corneal opacities with PTK and mitomycin C.
Read the detailed description
Epidemic keratoconjunctivitis is a very common disease, some patients developed a complication after the infection wich is corneal infiltration. Topical treatment sometimes helps to avoid loss of visual acuity. Therefore recurrence of the opacities after topical drops is observed. When corneal fibrosis occur is difficult to achieve visual rehabilitation with topical approach. This study evaluate pre and postoperative data of patients with subepithelial fibrosis caused by adenoviral infiltrates submitted to phototherapeutic keratectomy (PTK) using mitomycin C.
- Conditions
- Keratitis, Corneal Opacity
- Being tested
- PTK with mitomycin in Adenoviral Opacities
- Keywords
- PTK, corneal opacity, mitomycin
- Medical subject headings
- Keratitis, Corneal Opacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTK with mitomycin in Adenoviral OpacitiesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive data, visual acuity, slit lamp findings, subjective evaluation, topography patterns, pachymetry measurements.
Measured: one year
Secondary outcomes (1)
wavefront analysis, anterior segment tomography data, corneal biomechanics data.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startApr 2006
- Primary completionMay 2008
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for KeratitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Ester S Yamazaki, MD, Principal investigator, Federal University of Sao Paulo - BrazilMauro S Campos, MD, Study chair, Federal University of Sao Paulo - Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492245
- Sponsor's protocol ID
- CEP0075/06
- Status last verified
- Jul 2008
- First submitted
- 26 Jun 2007
- Last updated
- 4 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Fagerholm P. Phototherapeutic keratectomy: 12 years of experience. Acta Ophthalmol Scand. 2003 Feb;81(1):19-32. doi: 10.1034/j.1600-0420.2003.00015.x.
PubMed 12631015Porges Y, Ben-Haim O, Hirsh A, Levinger S. Phototherapeutic keratectomy with mitomycin C for corneal haze following photorefractive keratectomy for myopia. J Refract Surg. 2003 Jan-Feb;19(1):40-3. doi: 10.3928/1081-597X-20030101-08.
PubMed 12553604Khurana RN, Li Y, Tang M, Lai MM, Huang D. High-speed optical coherence tomography of corneal opacities. Ophthalmology. 2007 Jul;114(7):1278-85. doi: 10.1016/j.ophtha.2006.10.033. Epub 2007 Feb 20.
PubMed 17307254Yamazaki ES, Ferraz CA, Hazarbassanov RM, Allemann N, Campos M. Phototherapeutic keratectomy for the treatment of corneal opacities after epidemic keratoconjunctivitis. Am J Ophthalmol. 2011 Jan;151(1):35-43.e1. doi: 10.1016/j.ajo.2010.07.028. Epub 2010 Nov 24.
PubMed 21109229
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phototherapeutic Keratectomy With Mitomycin C in Adenoviral Infiltrates
- ClinicalTrials.gov ID
- NCT00492245
- Acronym / sponsor ID
- CEP0075/06
- Conditions
- Keratitis, Corneal Opacity
- Keywords
- PTK, corneal opacity, mitomycin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- May 2008
- Study completion
- Dec 2008 (estimated)
- First posted
- 27 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.
The present study was designed to evaluate the treatment of adenoviral corneal opacities with PTK and mitomycin C.
Detailed description
Epidemic keratoconjunctivitis is a very common disease, some patients developed a complication after the infection wich is corneal infiltration. Topical treatment sometimes helps to avoid loss of visual acuity. Therefore recurrence of the opacities after topical drops is observed. When corneal fibrosis occur is difficult to achieve visual rehabilitation with topical approach. This study evaluate pre and postoperative data of patients with subepithelial fibrosis caused by adenoviral infiltrates submitted to phototherapeutic keratectomy (PTK) using mitomycin C.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- visual acuity worse than 20/40, caused by central subepithelial fibrosis
Key exclusion criteria (2 listed)
- pregnancy, age less than 18 years-old or more than 80 years-old.
- diabetes, autoimmune diseases, corneal thickness less tha 400 micron.
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 |
|---|---|---|
| PTK with mitomycin in Adenoviral Opacities | Procedure or surgery | – |
Primary outcome
Refractive data, visual acuity, slit lamp findings, subjective evaluation, topography patterns, pachymetry measurements.
Time frame: one year
1 secondary outcome
wavefront analysis, anterior segment tomography data, corneal biomechanics data.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2008.
- Background: PubMed 12631015Fagerholm P. Phototherapeutic keratectomy: 12 years of experience. Acta Ophthalmol Scand. 2003 Feb;81(1):19-32. doi: 10.1034/j.1600-0420.2003.00015.x.
- Background: PubMed 12553604Porges Y, Ben-Haim O, Hirsh A, Levinger S. Phototherapeutic keratectomy with mitomycin C for corneal haze following photorefractive keratectomy for myopia. J Refract Surg. 2003 Jan-Feb;19(1):40-3. doi: 10.3928/1081-597X-20030101-08.
- Background: PubMed 17307254Khurana RN, Li Y, Tang M, Lai MM, Huang D. High-speed optical coherence tomography of corneal opacities. Ophthalmology. 2007 Jul;114(7):1278-85. doi: 10.1016/j.ophtha.2006.10.033. Epub 2007 Feb 20.
- Derived from this study: PubMed 21109229Yamazaki ES, Ferraz CA, Hazarbassanov RM, Allemann N, Campos M. Phototherapeutic keratectomy for the treatment of corneal opacities after epidemic keratoconjunctivitis. Am J Ophthalmol. 2011 Jan;151(1):35-43.e1. doi: 10.1016/j.ajo.2010.07.028. Epub 2010 Nov 24.
Related trials for Keratitis
RecruitingPhase 1/2
A Phase 1/2, Single-Dose, Multicenter, Dose Escalation, Clinical Trial to Evaluate the Safety and Efficacy of MR-146: An Open-Label Part 1 in Participants With Stage 1 or 2 Neurotrophic Keratopathy and a Double-Masked Part 2 in Participants With Stage 2 Neurotrophic Keratopathy
Neurotrophic Keratopathy
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
RecruitingPhase 2
Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
Corneal Ulcer
Not yet recruitingPhase 2
Trial to Evaluate the Efficacy And Safety of IVIEW-1201 In the Treatment of Fungal Keratitis
Fungal Keratitis
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
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.
Ester S Yamazaki, MD principal investigator
Federal University of Sao Paulo - Brazil
Mauro S Campos, MD study chair
Federal University of Sao Paulo - Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTK with mitomycin in Adenoviral Opacities in people with Keratitis and Corneal Opacity, run by Federal University of São Paulo at 1 site in Brazil.
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 2 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 4 Aug 2008. 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 Brazil. 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?
Results are not available in the source record.
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?
Refractive data, visual acuity, slit lamp findings, subjective evaluation, topography patterns, pachymetry measurements. (time frame: one year). 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 NCT00492245, which also lists 4 linked publications.
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 4 Aug 2008.