Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2016-04-30
2017-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Photorefractive Keratectomy and Corneal Cross-linking in Keratoconus
NCT02189447
Astigmatic Vector Analysis of Posterior Cornea - a Comparison Among Healthy, Forme Fruste and Overt Keratoconus Corneas
NCT02698709
Evaluation of the Keratoconic Cornea After Corneal Collagen Cross Linking.
NCT03879421
Validation of Innovative Scheimpflug Topography Derived RGP Contact Lens Designs In Optometry Network
NCT06312163
Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty
NCT00566605
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Lumera Microscope with OCT RESCAN
corneal transplantation guided by Lumera Microscope with OCT RESCAN
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
Conventional Microscope
corneal transplantation guided by Conventional Microscope
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lumera Microscope with OCT RESCAN
corneal transplantation guided by Lumera Microscope with OCT RESCAN
Conventional Microscope
corneal transplantation guided by Conventional Microscope
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 18 years at least
* Diagnostic of the following diseases:
* keratoconus
* Keratopathy Bullosa
* Corneal dystrophy
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eye Clinic Day Hospital, São Paulo
OTHER
Federal University of São Paulo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Walton Nose
Professor of Ophthalmology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Walton Nose, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo UNIFESP
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RESCAN2016
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.