PterygiumNCT00704977
Alcohol 20% for Separation of Pterygium and Comparison of Different Wound Closure Methods
A study testing pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure technique in people with Pterygium, run by Soroka University Medical Center at 2 sites in Israel.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pterygium
- What is being tested?
- pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesIsrael
- Study dates
- Jun 2008to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age- above 18 years old.
- Primary pterygium.
- Eligibility to sign the informed consent.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Soroka University Medical Center, Ophthalmology department and outpatient clinics
Beersheba
Tova Lifshitz, MD, 972-8-6400288, Toval@bgu.ac.il
Anry Pitchkhadze, MD, 972-8-6400556, anrypi@clalit.org.il
- Recruiting
Soroka University Medical Center
Beersheba
Tova Lifshitz, MD, 972-8-6400288, toval@bgu.ac.il
Anry Pitchkhadze, MD, 972-8-6400556, anrypi@clalit.org.il
About this study
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
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
Read the 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.
- Conditions
- Pterygium
- Being tested
- pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure technique
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Pterygium surgery using alcohol 20% + wound closure by bare sclera technique Receives: Procedure: pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure technique |
| 2 | Active comparator | 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 Receives: Procedure: pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure technique |
| 3 | Active comparator | 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) Receives: Procedure: pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
Measured: during first 3 months
pterygium recurrence
Measured: at least 1 year
Secondary outcomes (4)
patient satisfaction
Measured: during 1 year
corneal topography
Measured: during 1 year
endothelial cell density
Measured: during 1 year
evaluation of risk factors for pterygium recurrence (ex. exposure to UV-light, family history ...)
Measured: during 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Tova Lifshitz, MD, Principal investigator, Professor, Chief of ophthalmology department and clinics, SorokaUniversity Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704977
- Sponsor's protocol ID
- sor471508ctil
- Status last verified
- Jun 2008
- First submitted
- 24 Jun 2008
- Last updated
- 25 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00704977
- Acronym / sponsor ID
- sor471508ctil
- Conditions
- Pterygium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 25 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure techniquePterygium surgery using alcohol 20% + wound closure by bare sclera technique |
| 2 | Active comparator | Procedure: pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure techniqueAlcohol 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 comparator | Procedure: pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure techniqueAlcohol 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age- above 18 years old.
- Primary pterygium.
- Eligibility to sign the informed consent.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure techniqueThe 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. | Procedure or surgery | 1, 2, 3 |
Primary outcome
postoperative complications
Time frame: during first 3 months
pterygium recurrence
Time frame: at least 1 year
4 secondary outcomes
patient satisfaction
Time frame: during 1 year
corneal topography
Time frame: during 1 year
endothelial cell density
Time frame: during 1 year
evaluation of risk factors for pterygium recurrence (ex. exposure to UV-light, family history ...)
Time frame: during 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tova Lifshitz, MD principal investigator
Professor, Chief of ophthalmology department and clinics, SorokaUniversity Medical Center, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure technique in people with Pterygium, run by Soroka University Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tova Lifshitz, MD (972-8-6400288, Toval@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications (time frame: during first 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2008.