Amniotic Membrane Graft In Syntomathic Bullous Keratopathy

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.

Conditions

• Bullous Keratopathy

Interventions

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

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.

Sponsors & Collaborators

• Instituto para el Desarrollo Biotecnológico y la Innovación S.A.

  collaborator OTHER

• Universidad de Granada

  collaborator OTHER

• Universidad de Valparaiso

  lead OTHER

Principal Investigators

• L. Venegas · Ophthalmology Unit, Van Buren Hospital, Valparaiso, Chile.

• M. Hettich · Ophthalmology Unit, Van Buren Hospital, Valparaiso, Chile.

• J. Villena · Biomedical Research Centre, School of Medicine, Universidad de Valparaiso, Chile.

• R. Aris · Biomedical Research Centre, School of Medicine, Universidad de Valparaiso, Chile.

• M. Párraga · Biomedical Research Centre, School of Medicine, Universidad de Valparaiso, Chile.

• O. Parolini · Centro di Ricerca E. Menni, Fondazione Poliambulanza-Istituto Ospedaliero, Brescia, Italy.

• M. Alaminos · Department of Histology, University of Granada, Spain

• A. Campos · Biomedical Research Centre, School of Medicine, Universidad de Valparaiso, Chile.

• S, San Martin · Biomedical Research Centre, School of Medicine, Universidad de Valparaiso, Chile.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2012-05-31

Completion

2012-06-30

Countries

• Chile

Study Locations