Corneal Transplantation Guided by OCT RESCAN

Not Applicable

• Conditions: Cornea; Bullous Keratopathy; Corneal Dystrophy; Keratoconus

• Registration Number: NCT02736877
• Lead Sponsor: Federal University of São Paulo

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

Study Timeline

• Study First Submitted: 2016-03-22
• Status Verified: 2016-04
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-08
• Last Update Submitted: 2016-04-08
• Study First Posted: 2016-04-13
• Last Update Posted: 2016-04-13
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assess optimal maneuvers in corneal transplantation (separation layers)	Day 0	assessed by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)

Secondary Outcome Measures

Name	Time	Method
Compare the time of surgery between groups	Day 0	by a questionnaire responded by surgeons (until 30 minutes, between 30-60 minutes, more than 60 minutes)
To describe the surgical difficulty for corneal transplantation	Day 0	by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
Change of Day 1 Ocular inflammation at 1 month (Day 30)	from Day1 to Day30	ocular inflammation scored as mild, moderate or severe
Change from Baseline Visual Acuity at 6 months (Day 180)	from Baseline to Day 180	visual acuity tested by ETDRS chart
Change from Baseline Intraocular Pressure at 6 months (Day180)	from Baseline to Day 180	intraocular pressure assessed by goldmann tonometer