Clinical trial NCT02736877: Corneal Transplantation Guided by OCT RESCAN
Official title: Corneal Transplantation Guided by OCT RESCAN: Pre-op, Intra-op and Post-op Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cornea
Keratoconus
Bullous Keratopathy
Corneal Dystrophy
Keywords: keratoconus
bullous keratopathy
corneal dystrophy
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Eye Clinic Day Hospital, São Paulo
First posted: 2016-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Participants will be allocated in one of the following groups:

1. Control Group The control group will undergo corneal transplant with conventional microscope without coupled OCT. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation (ANNEX 1).
2. Group OCT RESCAN In the group microscope coupled to OCT, patients will undergo retinal surgery using the Lumera Microscope WITH RESCAN OCT - ZEISS. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation (ANNEX 1).

The investigators will evaluate intraoperative conditions, complications, operative time and postoperative results in both groups.

All patients will be monitored and evaluated with full ophthalmological examination in all postoperative visits (day 1, 7,15,30, 60, 90, 180) and will be subjected to the following tests:

* Measurement of visual acuity with best correction
* Previous Biomicroscopy
* Corneal Topography
* tonometry
* Optical coherence tomography (OCT)
* Microscopy speculate

Eligibility criteria: 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

Primary outcomes:
measure: Assess optimal maneuvers in corneal transplantation (separation layers)
timeFrame: Day 0
Secondary outcomes:
measure: Compare the time of surgery between groups
timeFrame: Day 0
measure: To describe the surgical difficulty for corneal transplantation
timeFrame: Day 0
measure: Change of Day 1 Ocular inflammation at 1 month (Day 30)
timeFrame: from Day1 to Day30
measure: Change from Baseline Intraocular Pressure at 6 months (Day180)
timeFrame: from Baseline to Day 180
measure: Change from Baseline Visual Acuity at 6 months (Day 180)
timeFrame: from Baseline to Day 180
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo UNIFESP
name: Walton Nose, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: