Keratoconus Clinical Trial
Official title:
Corneal Transplantation Guided by OCT RESCAN: Pre-op, Intra-op and Post-op Evaluation
The investigators will evaluate 30 patients with surgical indication for corneal
transplantation. Participants will be divided according to the following diseases diseases:
keratoconus, bullous keratopathy, corneal dystrophies. Participants will be informed about
the risks and benefits of the study and sign an informed consent form. In the preoperative
evaluation will be submitted to a complete ophthalmologic examination with complementary
tests, such as optical coherence tomography.
One group of participants will undergo corneal surgery using the OCT Lumera microscope
RESCAN - ZEISS and another group with a conventional microscope. Everyone will have their
filmed and documented surgery. The team of surgeons will answer the questionnaire on the
surgical difficulty about the ease of assessing corneal transplantation. After surgery,
participants will be assessed on days 1, 7,15, 30, 60, 90 and 180 after surgery.
Surgeries and study procedures will be performed by the same team of surgeons and performed
by IPEPO - Paulista Institute of Studies and Research in Ophthalmology / Vision Institute.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | March 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Visual acuity less than 20/60 in the affected eye - 18 years at least - Diagnostic of the following diseases: - keratoconus - Keratopathy Bullosa - Corneal dystrophy Exclusion Criteria: - Better visual acuity than or equal to 20/60 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo | Eye Clinic Day Hospital, São Paulo |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess optimal maneuvers in corneal transplantation (separation layers) | assessed by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty) | Day 0 | Yes |
Secondary | Compare the time of surgery between groups | by a questionnaire responded by surgeons (until 30 minutes, between 30-60 minutes, more than 60 minutes) | Day 0 | No |
Secondary | To describe the surgical difficulty for corneal transplantation | by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty) | Day 0 | No |
Secondary | Change of Day 1 Ocular inflammation at 1 month (Day 30) | ocular inflammation scored as mild, moderate or severe | from Day1 to Day30 | Yes |
Secondary | Change from Baseline Intraocular Pressure at 6 months (Day180) | intraocular pressure assessed by goldmann tonometer | from Baseline to Day 180 | Yes |
Secondary | Change from Baseline Visual Acuity at 6 months (Day 180) | visual acuity tested by ETDRS chart | from Baseline to Day 180 | Yes |
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