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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02736877
Other study ID # RESCAN2016
Secondary ID
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


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
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