Corneal Transplantation Guided by OCT RESCAN

NCT02736877 | Unknown

• 1 other identifier: RESCAN2016
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cornea; Keratoconus; Bullous Keratopathy; Corneal Dystrophy

Keywords

keratoconus; bullous keratopathy; corneal dystrophy

Outcome Measures

Primary Outcomes (1)

• Assess optimal maneuvers in corneal transplantation (separation layers)

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

  Day 0

Secondary Outcomes (5)

• Compare the time of surgery between groups

  Day 0

• To describe the surgical difficulty for corneal transplantation

  Day 0

• Change of Day 1 Ocular inflammation at 1 month (Day 30)

  from Day1 to Day30

• Change from Baseline Intraocular Pressure at 6 months (Day180)

  from Baseline to Day 180

• Change from Baseline Visual Acuity at 6 months (Day 180)

  from Baseline to Day 180

Study Arms (2)

Lumera Microscope with OCT RESCAN

EXPERIMENTAL

In the group microscope coupled to OCT, patients will undergo corneal surgery using the Lumera Microscope WITH RESCAN OCT - ZEISS. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation

Procedure: Lumera Microscope with OCT RESCAN

Conventional Microscope

ACTIVE COMPARATOR

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

Procedure: Conventional Microscope

Interventions

Lumera Microscope with OCT RESCAN PROCEDURE

corneal transplantation guided by Lumera Microscope with OCT RESCAN

Lumera Microscope with OCT RESCAN

Conventional Microscope PROCEDURE

corneal transplantation guided by Conventional Microscope

Conventional Microscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Visual acuity less than 20/60 in the affected eye
• years at least
• Diagnostic of the following diseases:
• keratoconus
• Keratopathy Bullosa
• Corneal dystrophy

You may not qualify if:

• Better visual acuity than or equal to 20/60

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Eye Clinic Day Hospital, São Paulo: collaborator

MeSH Terms

Conditions

Corneal Diseases; Keratoconus; Corneal Dystrophies, Hereditary

Condition Hierarchy (Ancestors)

Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Walton Nose, MD, PhD

  Federal University of São Paulo UNIFESP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo Nose, MD

CONTACT

5511 984471694; ricnose@gmail.com

Luci Silva, PhD

CONTACT

+551155726443; luci.silva@unifesp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 13, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 13, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share