Alcohol 20% for Separation of Pterygium and Comparison of Different Wound Closure Methods
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
1 other identifier
interventional
150
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2008
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 24, 2008
CompletedFirst Posted
Study publicly available on registry
June 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJune 25, 2008
June 1, 2008
2.1 years
June 24, 2008
June 24, 2008
Conditions
Outcome Measures
Primary Outcomes (2)
postoperative complications
during first 3 months
pterygium recurrence
at least 1 year
Secondary Outcomes (4)
patient satisfaction
during 1 year
corneal topography
during 1 year
endothelial cell density
during 1 year
evaluation of risk factors for pterygium recurrence (ex. exposure to UV-light, family history ...)
during 1 year
Study Arms (3)
1
ACTIVE COMPARATORPterygium surgery using alcohol 20% + wound closure by bare sclera technique
2
ACTIVE COMPARATORAlcohol 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
3
ACTIVE COMPARATORAlcohol 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)
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age- above 18 years old.
- Primary pterygium.
- Eligibility to sign the informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Soroka University Medical Center, Ophthalmology department and outpatient clinics
Beersheba, Israel
Soroka University Medical Center
Beersheba, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tova Lifshitz, MD
Professor, Chief of ophthalmology department and clinics, SorokaUniversity Medical Center, Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 24, 2008
First Posted
June 25, 2008
Study Start
June 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
June 25, 2008
Record last verified: 2008-06