Corneal Transplantation Guided by OCT RESCAN

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

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.

Study Overview

• Status: Unknown
• Conditions: Keratoconus; Cornea; Bullous Keratopathy; Corneal Dystrophy
• Intervention / Treatment: Procedure: Lumera Microscope with OCT RESCAN; Procedure: Conventional Microscope

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ricardo Nose, MD; Phone Number: 5511 984471694; Email: ricnose@gmail.com
• Study Contact Backup: Name: Luci Silva, PhD; Phone Number: +551155726443; Email: luci.silva@unifesp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumera Microscope with OCT RESCAN; 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; corneal transplantation guided by Lumera Microscope with OCT RESCAN
Active Comparator: Conventional Microscope; 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; corneal transplantation guided by Conventional Microscope

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Eye Clinic Day Hospital, São Paulo
• Investigators: Principal Investigator: Walton Nose, MD, PhD, Federal University of São Paulo UNIFESP

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: March 22, 2016
• First Submitted That Met QC Criteria: April 8, 2016
• First Posted (Estimate): April 13, 2016

Study Record Updates

• Last Update Posted (Estimate): April 13, 2016
• Last Update Submitted That Met QC Criteria: April 8, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: keratoconus; bullous keratopathy; corneal dystrophy
• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Keratoconus; Corneal Dystrophies, Hereditary
• Other Study ID Numbers: RESCAN2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: scientific publication