Corneal Transplantation Guided by OCT RESCAN

NCT02736877 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-04-13

No results posted yet for this study

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.

Conditions

  • Cornea
  • Keratoconus
  • Bullous Keratopathy
  • Corneal Dystrophy

Interventions

PROCEDURE

Lumera Microscope with OCT RESCAN

corneal transplantation guided by Lumera Microscope with OCT RESCAN

PROCEDURE

Conventional Microscope

corneal transplantation guided by Conventional Microscope

Sponsors & Collaborators

  • Eye Clinic Day Hospital, São Paulo

    collaborator OTHER
  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Walton Nose, MD, PhD · Federal University of São Paulo UNIFESP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-12-31
Completion
2017-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02736877 on ClinicalTrials.gov