Corneal DiseaseALKSBKNCT00654888
Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy
A study testing ALK (automated lamellar keratectomy) and Mitomycin in people with Corneal Disease, run by Federal University of São Paulo.
Trial summary
To relieve pain in patients with symptomatic bullous keratopathy (BK) until keratoplasty and in patients without visual prediction. The automated lamellar keratectomy represents a alternative in treatment of pain in symptomatic patients with BK. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Corneal Disease
- What is being tested?
- ALK (automated lamellar keratectomy) and Mitomycin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Feb 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with bullous keratopathy symptomatic (with pain)
Who cannot join
- herpetic endotelial disorders
About this study
Official title: Study of Automated Lamellar Keratectomy With a New Option in Treatment in Symptomatic Patients With Bullous Keratopathy.
To relieve pain in patients with symptomatic bullous keratopathy (BK) until keratoplasty and in patients without visual prediction.
The automated lamellar keratectomy represents a alternative in treatment of pain in symptomatic patients with BK.
Read the detailed description
Only patients with BK symptomatic (with pain) were submitted to automated lamellar keratectomy (ALK).
Complete ophthalmological examination including UCVA,BSVA, biomicroscopy, tonometry, esthesiometry, UBM pachymetry, impression cytology and pain questionnaire were performed in preoperative, postoperative of one, seven, 30, 90, 180 days and one year.
- Conditions
- Corneal Disease
- Being tested
- ALK (automated lamellar keratectomy), Mitomycin
- Keywords
- cataract extraction, surgery, corneal disease
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALK (automated lamellar keratectomy)Procedure or surgery
Also called automated lamellar keratectomy with PTK
ALK is performed with a microkeratome, to make a free cap.
MitomycinDrug
Also called automated lamellar keratectomy associated with PTK
mitomycin 0,02%, 30 seconds after ALK
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Group one submitted to automated lamellar keratectomy(ALK) with mitomycin (0,02% in 30 seconds after keratectomy). Receives: Drug: Mitomycin |
| 2 | Active comparator | automated lamellar keratectomy without mitomycin Receives: Procedure: ALK (automated lamellar keratectomy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain questionnaire
Measured: preoperative and postoperative 1,7,30,90,180 days and one year
Secondary outcomes (1)
biomicroscopy, esthesiometry, UBM pachymetry, impression cytology
Measured: preoperative, postoperative 1,7,30,90,180 days and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startMar 2005
- Primary completionMar 2006
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Eliana D Gonçalves, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654888
- Sponsor's protocol ID
- 0068/05
- Acronym
- ALKSBK
- Status last verified
- Apr 2008
- First submitted
- 3 Apr 2008
- Last updated
- 11 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Automated Lamellar Keratectomy With a New Option in Treatment in Symptomatic Patients With Bullous Keratopathy.
- ClinicalTrials.gov ID
- NCT00654888
- Acronym / sponsor ID
- ALKSBK / 0068/05
- Conditions
- Corneal Disease
- Keywords
- cataract extraction, surgery, corneal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 9 Apr 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.
To relieve pain in patients with symptomatic bullous keratopathy (BK) until keratoplasty and in patients without visual prediction.
The automated lamellar keratectomy represents a alternative in treatment of pain in symptomatic patients with BK.
Detailed description
Only patients with BK symptomatic (with pain) were submitted to automated lamellar keratectomy (ALK).
Complete ophthalmological examination including UCVA,BSVA, biomicroscopy, tonometry, esthesiometry, UBM pachymetry, impression cytology and pain questionnaire were performed in preoperative, postoperative of one, seven, 30, 90, 180 days and one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: MitomycinGroup one submitted to automated lamellar keratectomy(ALK) with mitomycin (0,02% in 30 seconds after keratectomy). |
| 2 | Active comparator | Procedure: ALK (automated lamellar keratectomy)automated lamellar keratectomy without mitomycin |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with bullous keratopathy symptomatic (with pain)
Key exclusion criteria (1 listed)
- herpetic endotelial disorders
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 |
|---|---|---|
| ALK (automated lamellar keratectomy)Also: automated lamellar keratectomy with PTKALK is performed with a microkeratome, to make a free cap. | Procedure or surgery | 2 |
| MitomycinAlso: automated lamellar keratectomy associated with PTKmitomycin 0,02%, 30 seconds after ALK | Drug | 1 |
Primary outcome
Pain questionnaire
Time frame: preoperative and postoperative 1,7,30,90,180 days and one year
1 secondary outcome
biomicroscopy, esthesiometry, UBM pachymetry, impression cytology
Time frame: preoperative, postoperative 1,7,30,90,180 days and one year
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 11 Apr 2008.
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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.
Eliana D Gonçalves, MD principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing ALK (automated lamellar keratectomy) and Mitomycin in people with Corneal Disease, run by Federal University of São Paulo.
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 1 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 11 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain questionnaire (time frame: preoperative and postoperative 1,7,30,90,180 days and one year). 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 11 Apr 2008.