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

Primary Purpose

Pterygium

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure technique
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Soroka University Medical Center, Ophthalmology department and outpatient clinicsRecruiting
  • Soroka University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Pterygium surgery using alcohol 20% + wound closure by bare sclera technique

Alcohol 20% for pterygium separation + wound closure by sliding flap technique. The main steps of surgery are described below.Wound closure technique is as follows. Disection of conjunctiva adjascent to the wound, bringing the dissected conjunctiva to the wound area and suturing by vicril 6/0 sutures

Alcohol 20 % for pterygium separation + using amniotic membrane and biological glue for wound closure. The steps of surgery are as described below, wound closure technique is as follows. Amniotic membrane is applied with its mesenchimal side to conjunctiva and glued by biological glue (main ingradients: calcium and thrombin)

Outcomes

Primary Outcome Measures

postoperative complications
pterygium recurrence

Secondary Outcome Measures

patient satisfaction
corneal topography
endothelial cell density
evaluation of risk factors for pterygium recurrence (ex. exposure to UV-light, family history ...)

Full Information

First Posted
June 24, 2008
Last Updated
June 24, 2008
Sponsor
Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00704977
Brief Title
Alcohol 20% for Separation of Pterygium and Comparison of Different Wound Closure Methods
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 Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Soroka University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Pterygium surgery using alcohol 20% + wound closure by bare sclera technique
Arm Title
2
Arm Type
Active Comparator
Arm Description
Alcohol 20% for pterygium separation + wound closure by sliding flap technique. The main steps of surgery are described below.Wound closure technique is as follows. Disection of conjunctiva adjascent to the wound, bringing the dissected conjunctiva to the wound area and suturing by vicril 6/0 sutures
Arm Title
3
Arm Type
Active Comparator
Arm Description
Alcohol 20 % for pterygium separation + using amniotic membrane and biological glue for wound closure. The steps of surgery are as described below, wound closure technique is as follows. Amniotic membrane is applied with its mesenchimal side to conjunctiva and glued by biological glue (main ingradients: calcium and thrombin)
Intervention Type
Procedure
Intervention Name(s)
pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure technique
Intervention Description
The eye operated is disinfected and covered according routine protocol. Tightly applying well above the pterygium area. Instilling alcohol 20% into the well and holding for 40-60 seconds. Absorbing alcohol by applicator and abundant irrigation with BSS. Pterygium separation starting 2 mm centrally from the edges of the tissue. Excising the pterygium tissue at the base. Applying mytomycin C for 2.5 min+ abundant irrigation with BSS. Wound closure by by technique described in each arm. Bandage with chloramphenicol ointment or with Maxitrol ointment (Dexamethasone/Neomycin/Polymyxin B Eye Ointment. Postoperative treatment include :antibiotic and steroid eyedrop treatment at least 2 weeks. Follow up at 1 week, 1 month, 3 months, 6 months, 1 year. If additional follow upvisits are needed - they will be accomplished according the patients condition and needs.
Primary Outcome Measure Information:
Title
postoperative complications
Time Frame
during first 3 months
Title
pterygium recurrence
Time Frame
at least 1 year
Secondary Outcome Measure Information:
Title
patient satisfaction
Time Frame
during 1 year
Title
corneal topography
Time Frame
during 1 year
Title
endothelial cell density
Time Frame
during 1 year
Title
evaluation of risk factors for pterygium recurrence (ex. exposure to UV-light, family history ...)
Time Frame
during 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tova Lifshitz, MD
Phone
972-8-6400288
Email
Toval@bgu.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Anry Pitchkhadze, MD
Phone
972-8-6400556
Email
anrypi@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tova Lifshitz, MD
Organizational Affiliation
Professor, Chief of ophthalmology department and clinics, SorokaUniversity Medical Center, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka University Medical Center, Ophthalmology department and outpatient clinics
City
Beer Sheva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tova Lifshitz, MD
Phone
972-8-6400288
Email
Toval@bgu.ac.il
First Name & Middle Initial & Last Name & Degree
Anry Pitchkhadze, MD
Phone
972-8-6400556
Email
anrypi@clalit.org.il
Facility Name
Soroka University Medical Center
City
Beer Sheva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tova Lifshitz, MD
Phone
972-8-6400288
Email
toval@bgu.ac.il
First Name & Middle Initial & Last Name & Degree
Anry Pitchkhadze, MD
Phone
972-8-6400556
Email
anrypi@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Tova Lifshitz, MD
First Name & Middle Initial & Last Name & Degree
Erez tsumi, MD
First Name & Middle Initial & Last Name & Degree
Anry Pitchkhadze, MD
First Name & Middle Initial & Last Name & Degree
Tova Monos, MD
First Name & Middle Initial & Last Name & Degree
Jaime Levy, MD
First Name & Middle Initial & Last Name & Degree
Avichai Segal, MD
First Name & Middle Initial & Last Name & Degree
Aliona Petrova, MD
First Name & Middle Initial & Last Name & Degree
Zach Ashkenazi, MD
First Name & Middle Initial & Last Name & Degree
Boris Knyazer, MD
First Name & Middle Initial & Last Name & Degree
Noam Yankulovich, MD
First Name & Middle Initial & Last Name & Degree
Ahed Amtirat, MD

12. IPD Sharing Statement

Learn more about this trial

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

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