Alcohol 20% for Separation of Pterygium and Comparison of Different Wound Closure Methods

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

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

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: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

postoperative complications

pterygium recurrence

Secondary outcome:

patient satisfaction

corneal 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.

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.

Tova Lifshitz, MD, Phone: 972-8-6400288, Email: Toval@bgu.ac.il

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

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

Starting date: June 2008
Ending date: July 2010
Last updated: June 24, 2008