Corneal Transplantation Guided by OCT RESCAN

Federal University of São Paulo

Status: Unknown

Conditions: Keratoconus; Bullous Keratopathy; Corneal Dystrophy; Cornea

Treatments: Procedure: Conventional Microscope; Procedure: Lumera Microscope with OCT RESCAN

Study type: Interventional

Funder types: Other

Identifiers

NCT02736877

RESCAN2016

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Lumera Microscope with OCT RESCAN

Experimental group

Description:

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

Treatment:

Procedure: Lumera Microscope with OCT RESCAN

Conventional Microscope

Active Comparator group

Description:

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

Treatment:

Procedure: Conventional Microscope