Alcohol 20% for Separation of Pterygium and Comparison of Different Wound Closure Methods
Information source: Soroka University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pterygium
Intervention: pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure technique (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Soroka University Medical Center Official(s) and/or principal investigator(s): Tova Lifshitz, MD, Principal Investigator, Affiliation: Professor, Chief of ophthalmology department and clinics, SorokaUniversity Medical Center, Israel
Overall contact: Tova Lifshitz, MD, Phone: 972-8-6400288, Email: Toval@bgu.ac.il
Summary
Purpose of this study is to evaluate efficiency and safety of Alcohol 20% for peeling
pterygium and to compare 3 different methods of operative wound closure: Bare sclera,
Sliding flap, Amniotic membrane + biological glue
Clinical Details
Official title: Evaluation of Alcohol 20% for Separation of Pterygium Tissue During Pterygium Surgery and Comparison of Three Different Methods of Wound Closure in Pterygium Surgery: Bare Sclera, Sliding Flap, Amniotic Membrane With Biological Glue
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: postoperative complicationspterygium recurrence
Secondary outcome: patient satisfactioncorneal topography endothelial cell density evaluation of risk factors for pterygium recurrence (ex. exposure to UV-light, family history ...)
Detailed description:
Pterygium is a fibrovascular tissue growing on conjunctiva and cornea. The
disturbance/morbidity caused by pterygium is diverse, ranging from mild esthetic disturbance
and till recurrent inflammations and significant decrease of visual acuity. Rate of
pterygium is between 20%-49% of general population, while increase in these numbers is
observed in the population of equatorial regions. Pterygium usually appears at age of 22-49
years. While the rate of pterygium appearance increases with the age, the recurrence rate
after surgical removal is higher in younger patients. Treatment of pterygium is surgical.
The main challenges during surgery are peeling of pterygium and prevention of recurrence.
During the last two decades several methods were developed and became widely accepted for
pterygium surgery. The emphasis in modifying pterygium surgery is done on initial phase of
surgery - techniques of pterygium separation and the final phase - the wound closure
methods, additionally adjuncts (such as Mitomycine C) became widely used. These
modifications are considered to improve the surgical outcomes and decrease the rate of
complications and recurrence rate. Currently popular techniques of pterygium separation
include Blunt dissection + keratectomy (blunt separation of the tissue + dissection of
superficial layers of cornea); Avulsion technique (Avulsion of the pterygium head by
creating tension on the cap edge+ further optional blunt dissection); Air assisted
dissection (injection of air into the side of pterygium cap to create good separation
plane).
Alcohol 20% is widely used in surface refractive surgery, where it helps to peel easily the
epithelium of the cornea. Several reports show a positive role of alcohol in treatment of
recurrent corneal erosions resistant to other treatments. At microscopic level - the ethanol
splits basement membrane at the level between lamina lucida and lamina densa, additionally
ethanol destroys the hemidesmosome junctions between epithelial cells. No consensus exists
on ethanol influence on keratocyte viability and function: some studies show delayed wound
healing and significant keratocyte damage, while other works show no significant alteration
in keratocyte number while using alcohol.
At the phase of pterygium separation our purpose is to check the safety and efficiency of
alcohol 20% for peeling of pterygium from ocular surface.
Various closure techniques exist, 3 of the widespread techniques are: Bare sclera (with
adjunct such as mitomycine C) - the wound is left as it is, without closure. Sliding
conjunctival flap- conjunctiva from adjacent region is dissected, moved to the wound area
and sutured. Amniotic membrane transplantation, using biological glue to adhere the
membrane. Amniotic membrane does not carry HLA antigens - so that no HLA compatibility tests
are needed. Amniotic membrane underwent screening of infectious diseases and was
cryopreserved. Amniotic membrane is applied with its mesenchimal part towards sclera and
basement membrane side upwards. Adhesion of amniotic membrane is achieved by biological glue
(containing thrombin and calcium as main ingredients)
We intend to compare each of these methods of wound closure in conjunction with using
alcohol 20 % for pterygium separation.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age- above 18 years old.
- Primary pterygium.
- Eligibility to sign the informed consent.
Exclusion Criteria:
- Unwillingness to participate in study.
- Hypersensitivity to materials/ medications used during the surgery.
- Pregnancy.
- Cases when the eye which should be operated is the only fuctional eye.
- Age less than 18 years old.
- Recurrent pterygium.
- Chronic eye diseases, especially ocular surface disorders such as: OCP, severe
blepharitis, severe keratoconjunctivitis,atopic eye disorders.
Patients which are not eligible to sign independently the informed consent.
Locations and Contacts
Tova Lifshitz, MD, Phone: 972-8-6400288, Email: Toval@bgu.ac.il
Soroka University Medical Center, Beer Sheva, Israel; Recruiting Tova Lifshitz, MD, Phone: 972-8-6400288, Email: toval@bgu.ac.il Anry Pitchkhadze, MD, Phone: 972-8-6400556, Email: anrypi@clalit.org.il Tova Lifshitz, MD, Principal Investigator Erez tsumi, MD, Sub-Investigator Anry Pitchkhadze, MD, Sub-Investigator Tova Monos, MD, Sub-Investigator Jaime Levy, MD, Sub-Investigator Avichai Segal, MD, Sub-Investigator Aliona Petrova, MD, Sub-Investigator Zach Ashkenazi, MD, Sub-Investigator Boris Knyazer, MD, Sub-Investigator Noam Yankulovich, MD, Sub-Investigator Ahed Amtirat, MD, Sub-Investigator
Soroka University Medical Center, Ophthalmology department and outpatient clinics, Beer Sheva, Israel; Recruiting Tova Lifshitz, MD, Phone: 972-8-6400288, Email: Toval@bgu.ac.il Anry Pitchkhadze, MD, Phone: 972-8-6400556, Email: anrypi@clalit.org.il
Additional Information
Starting date: June 2008
Last updated: June 24, 2008
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