Clinical Trial: Corneal Transplantation Guided by OCT RESCAN

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Corneal Transplantation Guided by OCT RESCAN: Pre-op, Intra-op and Post-op Evaluation

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 Summary:

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

Sponsor: Federal University of São Paulo

Current Primary Outcome: Assess optimal maneuvers in corneal transplantation (separation layers) [ Time Frame: Day 0 ]

assessed by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Compare the time of surgery between groups [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: from Day1 to Day30 ]
    ocular inflammation scored as mild, moderate or severe
  • Change from Baseline Intraocular Pressure at 6 months (Day180) [ Time Frame: from Baseline to Day 180 ]
    intraocular pressure assessed by goldmann tonometer
  • Change from Baseline Visual Acuity at 6 months (Day 180) [ Time Frame: from Baseline to Day 180 ]
    visual acuity tested by ETDRS chart


Original Secondary Outcome: Same as current

Information By: Federal University of São Paulo

Dates:
Date Received: March 22, 2016
Date Started: April 2016
Date Completion: March 2017
Last Updated: April 8, 2016
Last Verified: April 2016