NCT01926535

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
Last Updated

August 26, 2013

Status Verified

August 1, 2013

Enrollment Period

6 months

First QC Date

August 15, 2013

Last Update Submit

August 22, 2013

Conditions

Bullous Keratopathy

Keywords

amniotic membranecontact lensbullous keratopathy

Outcome Measures

Primary Outcomes (1)

  • Ocular pain

    Evaluated by using a visual analogue scale ranging from 0 to 10

    6 months

Secondary Outcomes (4)

  • Visual acuity

    6 months

  • Corneal Neovascularization

    6 months

  • Corneal epithelial defects

    6 months

  • Complications

    6 months

Other Outcomes (3)

  • Age

    At the enrolling moment

  • Sex

    At the enrolling moment

  • Affected eye

    At the enrolling moment

Study Arms (2)

Implant of amniotic membrane grafts

EXPERIMENTAL

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

Therapeutic contact lenses

ACTIVE COMPARATOR

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

Interventions

Implant of amniotic membrane graftsPROCEDURE

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

Implant of amniotic membrane grafts
Therapeutic contact lensesDEVICE

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.

Therapeutic contact lenses

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Valparaíso

Valparaíso, Región de Valparaíso, Chile

Location

Related Publications (21)

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

    BACKGROUND

  • Courtright P, Lewallen S, Holland SP, Wendt TM. Corneal decompensation after cataract surgery. An outbreak investigation in Asia. Ophthalmology. 1995 Oct;102(10):1461-5. doi: 10.1016/s0161-6420(95)30845-7.

    PMID: 9097792BACKGROUND

  • Canner JK, Javitt JC, McBean AM. National outcomes of cataract extraction. III. Corneal edema and transplant following inpatient surgery. Arch Ophthalmol. 1992 Aug;110(8):1137-42. doi: 10.1001/archopht.1992.01080200117038.

    PMID: 1497529BACKGROUND

  • Cosar CB, Sridhar MS, Cohen EJ, Held EL, Alvim Pde T, Rapuano CJ, Raber IM, Laibson PR. Indications for penetrating keratoplasty and associated procedures, 1996-2000. Cornea. 2002 Mar;21(2):148-51. doi: 10.1097/00003226-200203000-00003.

    PMID: 11862083BACKGROUND

  • Maeno A, Naor J, Lee HM, Hunter WS, Rootman DS. Three decades of corneal transplantation: indications and patient characteristics. Cornea. 2000 Jan;19(1):7-11. doi: 10.1097/00003226-200001000-00002.

    PMID: 10632000BACKGROUND

  • Jablonski J, Szafran B, Cichowska M. [Treatment of corneal complications after cataract surgery with soft contact lenses]. Klin Oczna. 1998;100(3):151-3. Polish.

    PMID: 9813997BACKGROUND

  • Smiddy WE, Hamburg TR, Kracher GP, Gottsch JD, Stark WJ. Therapeutic contact lenses. Ophthalmology. 1990 Mar;97(3):291-5. doi: 10.1016/s0161-6420(90)32589-7.

    PMID: 2336266BACKGROUND

  • Leibowitz HM, Rosenthal P. Hydrophilic contact lenses in corneal disease. II. Bullous keratopathy. Arch Ophthalmol. 1971 Mar;85(3):283-5. doi: 10.1001/archopht.1971.00990050285006. No abstract available.

    PMID: 5542864BACKGROUND

  • Kim JC, Tseng SC. Transplantation of preserved human amniotic membrane for surface reconstruction in severely damaged rabbit corneas. Cornea. 1995 Sep;14(5):473-84.

    PMID: 8536460BACKGROUND

  • Kim JC, Tseng SC. The effects on inhibition of corneal neovascularization after human amniotic membrane transplantation in severely damaged rabbit corneas. Korean J Ophthalmol. 1995 Jun;9(1):32-46. doi: 10.3341/kjo.1995.9.1.32.

    PMID: 7674551BACKGROUND

  • Sangwan VS, Burman S, Tejwani S, Mahesh SP, Murthy R. Amniotic membrane transplantation: a review of current indications in the management of ophthalmic disorders. Indian J Ophthalmol. 2007 Jul-Aug;55(4):251-60. doi: 10.4103/0301-4738.33036.

    PMID: 17595472BACKGROUND

  • Georgiadis NS, Ziakas NG, Boboridis KG, Terzidou C, Mikropoulos DG. Cryopreserved amniotic membrane transplantation for the management of symptomatic bullous keratopathy. Clin Exp Ophthalmol. 2008 Mar;36(2):130-5. doi: 10.1111/j.1442-9071.2008.01696.x.

    PMID: 18352868BACKGROUND

  • Lee HI, Ha SW, Kim JC. A novel application of amniotic membrane in patients with bullous keratopathy. J Korean Med Sci. 2006 Apr;21(2):324-8. doi: 10.3346/jkms.2006.21.2.324.

    PMID: 16614522BACKGROUND

  • Lopez Ferrando N, Celis Sanchez J, Gonzalez Del Valle F, Lopez Mondejar E. [Monolayered amniotic membrane transplantation as a palliative treatment for bullous keratopathy]. Arch Soc Esp Oftalmol. 2004 Jan;79(1):27-31. doi: 10.4321/s0365-66912004000100007. Spanish.

    PMID: 14752699BACKGROUND

  • Espana EM, Grueterich M, Sandoval H, Solomon A, Alfonso E, Karp CL, Fantes F, Tseng SC. Amniotic membrane transplantation for bullous keratopathy in eyes with poor visual potential. J Cataract Refract Surg. 2003 Feb;29(2):279-84. doi: 10.1016/s0886-3350(02)01525-0.

    PMID: 12648638BACKGROUND

  • Panda A, Pangtey MS, Sony P. Response to symptomatic management of postoperative bullous keratopathy with nonpreserved human amniotic membrane. Cornea. 2003 Mar;22(2):187; author reply 187-8. doi: 10.1097/00003226-200303000-00024. No abstract available.

    PMID: 12605061BACKGROUND

  • Mejia LF, Santamaria JP, Acosta C. Symptomatic management of postoperative bullous keratopathy with nonpreserved human amniotic membrane. Cornea. 2002 May;21(4):342-5. doi: 10.1097/00003226-200205000-00002.

    PMID: 11973379BACKGROUND

  • Pires RT, Tseng SC, Prabhasawat P, Puangsricharern V, Maskin SL, Kim JC, Tan DT. Amniotic membrane transplantation for symptomatic bullous keratopathy. Arch Ophthalmol. 1999 Oct;117(10):1291-7. doi: 10.1001/archopht.117.10.1291.

    PMID: 10532436BACKGROUND

  • Shimmura S, Shimazaki J, Ohashi Y, Tsubota K. Antiinflammatory effects of amniotic membrane transplantation in ocular surface disorders. Cornea. 2001 May;20(4):408-13. doi: 10.1097/00003226-200105000-00015.

    PMID: 11333331BACKGROUND

  • Adinolfi M, Akle CA, McColl I, Fensom AH, Tansley L, Connolly P, Hsi BL, Faulk WP, Travers P, Bodmer WF. Expression of HLA antigens, beta 2-microglobulin and enzymes by human amniotic epithelial cells. Nature. 1982 Jan 28;295(5847):325-7. doi: 10.1038/295325a0. No abstract available.

    PMID: 6173762BACKGROUND

  • Akle CA, Adinolfi M, Welsh KI, Leibowitz S, McColl I. Immunogenicity of human amniotic epithelial cells after transplantation into volunteers. Lancet. 1981 Nov 7;2(8254):1003-5. doi: 10.1016/s0140-6736(81)91212-5.

    PMID: 6118474BACKGROUND

Related Links

Study Officials

  • 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.

    PRINCIPAL INVESTIGATOR

  • S, San Martin

    Biomedical Research Centre, School of Medicine, Universidad de Valparaiso, Chile.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interno de Medicina

Study Record Dates

First Submitted

August 15, 2013

First Posted

August 21, 2013

Study Start

November 1, 2011

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

August 26, 2013

Record last verified: 2013-08

Locations

CL(1)