Corneal Transplantation Guided by OCT RESCAN

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02736877
• Other study ID #: RESCAN2016
• Status: Not yet recruiting
• Phase: N/A
• First received: March 22, 2016
• Last updated: April 8, 2016
• Start date: April 2016
• Est. completion date: March 2017

Study information

• Verified date: April 2016
• Source: Federal University of São Paulo
• Contact: Ricardo Nose, MD
• Phone: 5511 984471694
• Email: ricnose[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bullous Keratopathy
• Cornea
• Corneal Dystrophies, Hereditary
• Corneal Dystrophy
• Keratoconus

Intervention

Procedure:
• Lumera Microscope with OCT RESCAN
corneal transplantation guided by Lumera Microscope with OCT RESCAN
• Conventional Microscope
corneal transplantation guided by Conventional Microscope

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Eye Clinic Day Hospital, São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess optimal maneuvers in corneal transplantation (separation layers)	assessed by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)	Day 0	Yes
Secondary	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	No
Secondary	To describe the surgical difficulty for corneal transplantation	by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)	Day 0	No
Secondary	Change of Day 1 Ocular inflammation at 1 month (Day 30)	ocular inflammation scored as mild, moderate or severe	from Day1 to Day30	Yes
Secondary	Change from Baseline Intraocular Pressure at 6 months (Day180)	intraocular pressure assessed by goldmann tonometer	from Baseline to Day 180	Yes
Secondary	Change from Baseline Visual Acuity at 6 months (Day 180)	visual acuity tested by ETDRS chart	from Baseline to Day 180	Yes