Corneal Transplantation Guided by OCT RESCAN

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02736877
• Collaborator: Eye Clinic Day Hospital, São Paulo (Other)
• Enrollment: 30
• Arms: 2
• Duration (Months): 11

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cornea; Keratoconus; Bullous Keratopathy; Corneal Dystrophy	Procedure: Lumera Microscope with OCT RESCAN; Procedure: Conventional Microscope	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Corneal Transplantation Guided by OCT RESCAN: Pre-op, Intra-op and Post-op Evaluation
• Study Start Date: Apr 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2016
• Anticipated Study Completion Date: Mar 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. To describe the surgical difficulty for corneal transplantation [Day 0]

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

3. Change of Day 1 Ocular inflammation at 1 month (Day 30) [from Day1 to Day30]

   ocular inflammation scored as mild, moderate or severe

4. Change from Baseline Intraocular Pressure at 6 months (Day180) [from Baseline to Day 180]

   intraocular pressure assessed by goldmann tonometer

5. Change from Baseline Visual Acuity at 6 months (Day 180) [from Baseline to Day 180]

   visual acuity tested by ETDRS chart

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Federal University of São Paulo
• Eye Clinic Day Hospital, São Paulo

Investigators

• Principal Investigator: Walton Nose, MD, PhD, Federal University of São Paulo UNIFESP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Walton Nose, Professor of Ophthalmology, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT02736877
• Other Study ID Numbers: RESCAN2016
• First Posted: Apr 13, 2016
• Last Update Posted: Apr 13, 2016
• Last Verified: Apr 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Walton Nose, Professor of Ophthalmology, Federal University of São Paulo: keratoconus; bullous keratopathy; corneal dystrophy
• Additional relevant MeSH terms: Keratoconus; Corneal Dystrophies, Hereditary

Study Results

No Results Posted as of Apr 13, 2016