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Trial record 18 of 328 for:    "Eye Diseases, Hereditary" OR "Peters plus syndrome"

Corneal Transplantation Guided by OCT RESCAN

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ClinicalTrials.gov Identifier: NCT02736877
Recruitment Status : Unknown
Verified April 2016 by Walton Nose, Federal University of São Paulo.
Recruitment status was:  Not yet recruiting
First Posted : April 13, 2016
Last Update Posted : April 13, 2016
Sponsor:
Collaborator:
Eye Clinic Day Hospital, São Paulo
Information provided by (Responsible Party):
Walton Nose, Federal University of São Paulo

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 Not Applicable

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  (Clinical Trial)
Estimated 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 : April 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017


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




Primary Outcome Measures :
  1. Assess optimal maneuvers in corneal transplantation (separation layers) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: from Day1 to Day30 ]
    ocular inflammation scored as mild, moderate or severe

  4. Change from Baseline Intraocular Pressure at 6 months (Day180) [ Time Frame: from Baseline to Day 180 ]
    intraocular pressure assessed by goldmann tonometer

  5. Change from Baseline Visual Acuity at 6 months (Day 180) [ Time Frame: from Baseline to Day 180 ]
    visual acuity tested by ETDRS chart



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736877


Contacts
Contact: Ricardo Nose, MD 5511 984471694 ricnose@gmail.com
Contact: Luci Silva, PhD +551155726443 luci.silva@unifesp.br

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)

Responsible Party: Walton Nose, Professor of Ophthalmology, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02736877     History of Changes
Other Study ID Numbers: RESCAN2016
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: scientific publication

Keywords provided by Walton Nose, Federal University of São Paulo:
keratoconus
bullous keratopathy
corneal dystrophy

Additional relevant MeSH terms:
Keratoconus
Corneal Dystrophies, Hereditary
Corneal Edema
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn