KeratoconusPhase 1NCT00566605
Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty
A Phase 1 study testing Penetrating keratoplasty with IntraLase and Penetrating keratoplasty with vacuum trephine in people with Keratoconus, run by Hospital Oftalmologico de Sorocaba at 1 site in Brazil.
Trial summary
To compare the early visual results and postoperative recovery between two groups of keratoconic patients - one group having undergone a traditional, mechanical vacuum trephine procedure while the second group underwent femtosecond-enabled penetrating keratoplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Penetrating keratoplasty with IntraLase and Penetrating keratoplasty with vacuum trephine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2007to Aug 2008
- Phase
- Phase 1
- 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
- Patients older than 18 years old, with keratoconus and corneal transplant indication
Who cannot join
- Exclusion criteria included different ocular pathology and a potential visual acuity of less than 20/40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visual Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty
To compare the early visual results and postoperative recovery between two groups of keratoconic patients - one group having undergone a traditional, mechanical vacuum trephine procedure while the second group underwent femtosecond-enabled penetrating keratoplasty.
- Conditions
- Keratoconus
- Being tested
- Penetrating keratoplasty with IntraLase, Penetrating keratoplasty with vacuum trephine
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penetrating keratoplasty with IntraLaseProcedure or surgery
penetrating keratoplasty with femtosecond laser shaped incisions- IntraLase TM (IntraLase Enabled Keratoplasty [IEK])
Penetrating keratoplasty with vacuum trephineProcedure or surgery
Group 2 - penetrating keratoplasty with vacuum trephine
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Not described Receives: Procedure: Penetrating keratoplasty with IntraLase |
| Group 2 | Active comparator | Not described Receives: Procedure: Penetrating keratoplasty with vacuum trephine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: 1 year
Secondary outcomes (1)
Pachimetry, Microscopy, Corneal topography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2007 (estimated)
- Study startAug 2007
- Study completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Oftalmologico de Sorocaba
- Sponsor type
- University, hospital or other
- Investigators
- Elissandro M Silva, Lindoso, Principal investigator, Hospital Oftalmologico de Sorocaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566605
- Sponsor's protocol ID
- 466.07
- Status last verified
- Nov 2007
- First submitted
- 29 Nov 2007
- Last updated
- 3 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty
- ClinicalTrials.gov ID
- NCT00566605
- Acronym / sponsor ID
- 466.07
- Conditions
- Keratoconus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Oftalmologico de SorocabaUniversity, hospital or other
- Study start
- Aug 2007
- Study completion
- Aug 2008 (estimated)
- First posted
- 3 Dec 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.
To compare the early visual results and postoperative recovery between two groups of keratoconic patients - one group having undergone a traditional, mechanical vacuum trephine procedure while the second group underwent femtosecond-enabled penetrating keratoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Penetrating keratoplasty with IntraLase |
| Group 2 | Active comparator | Procedure: Penetrating keratoplasty with vacuum trephine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 18 years old, with keratoconus and corneal transplant indication
Key exclusion criteria (1 listed)
- Exclusion criteria included different ocular pathology and a potential visual acuity of less than 20/40
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 |
|---|---|---|
| Penetrating keratoplasty with IntraLasepenetrating keratoplasty with femtosecond laser shaped incisions- IntraLase TM (IntraLase Enabled Keratoplasty [IEK]) | Procedure or surgery | Group 1 |
| Penetrating keratoplasty with vacuum trephineGroup 2 - penetrating keratoplasty with vacuum trephine | Procedure or surgery | Group 2 |
Primary outcome
Visual acuity
Time frame: 1 year
1 secondary outcome
Pachimetry, Microscopy, Corneal topography
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2007.
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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.
Elissandro M Silva, Lindoso principal investigator
Hospital Oftalmologico de Sorocaba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Penetrating keratoplasty with IntraLase and Penetrating keratoplasty with vacuum trephine in people with Keratoconus, run by Hospital Oftalmologico de Sorocaba 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 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: status not confirmed, as of the sponsor's last update on 3 Dec 2007. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Visual acuity (time frame: 1 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 3 Dec 2007.