Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Amniotic Membrane Graft In Syntomathic Bullous Keratopathy (AMBUK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01926535
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : August 26, 2013
Sponsor:
Collaborators:
Investigación y Desarrollo Biotecnológico para Mejorar la Calidad de Vida de las Personas
Universidad de Granada
Information provided by (Responsible Party):
RICARDO ARIS, Universidad de Valparaiso

Brief Summary:

The amniotic membrane (AM) is an avascular structure derived from fetus, which is a good choice for regenerative medicine and effective treatment in eye surface pathologies such as bullous keratopathy (BK). This disease generates a chronic corneal edema evolving to the production of vesicles and bullae, chronic eye pain and visual acuity decrease.

Definitive treatment for those patients is corneal transplant; however, donation is not always available and thus requires long waiting times. The currently available palliative treatment consists in the use of contact lenses to prevent the corneal epithelium from falling. However, this may be associated with corneal neovascularization, lens displacement or loss, infections, and discomfort for the patient.

The objective of this work was to compare the use of amniotic membrane grafts versus contact lenses in patients suffering from BK awaiting a corneal transplant.

A randomized clinical trial assay was performed with patients with a clinical diagnosis of BK. Twenty patients were randomized into 2 groups: amniotic membrane and therapeutic contact lenses. Eye pain intensity (Analog visual scale), visual acuity (Snellen questioner), bullae and corneal epithelial defects presence, as well as corneal neovascularization and complications (biomicroscopy) were compared during 6 months.


Condition or disease Intervention/treatment Phase
Bullous Keratopathy Procedure: Implant of amniotic membrane grafts Device: Therapeutic contact lenses Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Analysis of Human Amniotic Membrane Graft Versus Contact Lenses in Syntomathic Bullous Keratopathy
Study Start Date : November 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Implant of amniotic membrane grafts
Amniotic membrane grafts were implanted in the affected eyes using topical anesthesia. Each graft was sutured to the bulbar conjunctive tissue using 10-0 nylon sutures and a reinforcement stitch was applied at the cornea
Procedure: Implant of amniotic membrane grafts
Amniotic membrane grafts were implanted in the affected eyes using topical anesthesia. Each graft was sutured to the bulbar conjunctive tissue using 10-0 nylon sutures and a reinforcement stitch was applied at the cornea

Active Comparator: Therapeutic contact lenses
Therapeutic contact lenses were applied in all patients and the lenses were replaced every two months according to the pre-established gold standard for this procedure.
Device: Therapeutic contact lenses
Therapeutic contact lenses were applied in all patients included in the control group and the lenses were replaced every two months according to the pre-established gold standard for this procedure.




Primary Outcome Measures :
  1. Ocular pain [ Time Frame: 6 months ]
    Evaluated by using a visual analogue scale ranging from 0 to 10


Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: 6 months ]
    Snellen scale

  2. Corneal Neovascularization [ Time Frame: 6 months ]
    Evaluation using a bio-microscope

  3. Corneal epithelial defects [ Time Frame: 6 months ]
    Evaluation using a bio-microscope per quadrant with fluorescein test

  4. Complications [ Time Frame: 6 months ]
    Evaluation using a bio-microscope


Other Outcome Measures:
  1. Age [ Time Frame: At the enrolling moment ]
    In years

  2. Sex [ Time Frame: At the enrolling moment ]
    Male or Female

  3. Affected eye [ Time Frame: At the enrolling moment ]
    left eye or right eye



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients with clinical diagnosis of symptomatic bullous keratopathy (corneal bullae, recurrent eye pain, foreign body sensation and photophobia), diagnosed at the Department of Ophthalmology Hospital Carlos Van Buren, Valparaiso, Chile, who were on the waiting list for corneal transplant from January 2008 to October 2011

Exclusion Criteria:

Excluded patients were those with medical contraindication to undergo surgery with topical anesthesia, patients with severe systemic conditions and patients with corneal infections.


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): NCT01926535


Locations
Layout table for location information
Chile
Universidad de Valparaíso
Valparaíso, Chile
Sponsors and Collaborators
Universidad de Valparaiso
Investigación y Desarrollo Biotecnológico para Mejorar la Calidad de Vida de las Personas
Universidad de Granada
Investigators
Layout table for investigator information
Principal Investigator: L. Venegas Ophthalmology Unit, Van Buren Hospital, Valparaiso, Chile.
Principal Investigator: M. Hettich Ophthalmology Unit, Van Buren Hospital, Valparaiso, Chile.
Principal Investigator: J. Villena Biomedical Research Centre, School of Medicine, Universidad de Valparaiso, Chile.
Principal Investigator: R. Aris Biomedical Research Centre, School of Medicine, Universidad de Valparaiso, Chile.
Principal Investigator: M. Párraga Biomedical Research Centre, School of Medicine, Universidad de Valparaiso, Chile.
Principal Investigator: O. Parolini Centro di Ricerca E. Menni, Fondazione Poliambulanza-Istituto Ospedaliero, Brescia, Italy.
Principal Investigator: M. Alaminos Department of Histology, University of Granada, Spain
Principal Investigator: A. Campos Biomedical Research Centre, School of Medicine, Universidad de Valparaiso, Chile.
Study Director: S, San Martin Biomedical Research Centre, School of Medicine, Universidad de Valparaiso, Chile.

Additional Information:
Publications:
Nishida T. Cornea: Fundamentals of cornea and external disease. St. Louis, Mosby. 1997; p. 3-27.

Layout table for additonal information
Responsible Party: RICARDO ARIS, Interno de Medicina, Universidad de Valparaiso
ClinicalTrials.gov Identifier: NCT01926535     History of Changes
Other Study ID Numbers: RARIS-001
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: August 2013

Keywords provided by RICARDO ARIS, Universidad de Valparaiso:
amniotic membrane
contact lens
bullous keratopathy

Additional relevant MeSH terms:
Layout table for MeSH terms
Corneal Edema
Corneal Diseases
Eye Diseases