PterygiumNCT00949728
Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia
A study testing Conjunctival autograft using fibrin glue in people with Pterygium and Primary, run by Hospital de Olhos Sadalla Amin Ghanem at 1 site in Brazil.
Trial summary
To evaluate the recurrence and postoperative complications rates after conjunctival autograft surgery using fibrin adhesive for primary pterygium Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Conjunctival autograft using fibrin glue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2006to Jul 2009
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of primary pterygium
- Symptomatic pterygium
- Limbal invasion
Who cannot join
- Secondary pterygium
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sadalla Amin Ghanem Eye Hospital
Joinville, Santa Catarina, 89201-010
About this study
To evaluate the recurrence and postoperative complications rates after conjunctival autograft surgery using fibrin adhesive for primary pterygium
- Being tested
- Conjunctival autograft using fibrin glue
- Keywords
- Pterygium, Autologous Transplantation, Conjunctiva, Fibrin Tissue Adhesive, Recurrence
- Medical subject headings
- Pterygium, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conjunctival autograft using fibrin glueProcedure or surgery
Also called Pterygium surgery using fibrin glue
Conjunctival autograft using fibrin glue in pterygium surgery
| Study group | Role | What they receive |
|---|---|---|
| Fibrin glue | Other | Not described Receives: Procedure: Conjunctival autograft using fibrin glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of pterygium after its excision with the conjunctival autograft technique.
Measured: One, three and five months after surgery.
Secondary outcomes (1)
Postoperative complications following the pterygium excision, such as partial graft detachment, dellen, granuloma or sutures failure.
Measured: One day, one week and one month after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startOct 2006
- Primary completionAug 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Olhos Sadalla Amin Ghanem
- Sponsor type
- University, hospital or other
- Investigators
- Renan F Oliveira, Principal investigatorRamon C Ghanem, M.D., Study director, Sadalla Amin Ghanem Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949728
- Sponsor's protocol ID
- cola106
- Status last verified
- Jul 2009
- First submitted
- 17 Jul 2009
- Last updated
- 30 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koranyi G, Seregard S, Kopp ED. Cut and paste: a no suture, small incision approach to pterygium surgery. Br J Ophthalmol. 2004 Jul;88(7):911-4. doi: 10.1136/bjo.2003.032854.
PubMed 15205236Bahar I, Weinberger D, Gaton DD, Avisar R. Fibrin glue versus vicryl sutures for primary conjunctival closure in pterygium surgery: long-term results. Curr Eye Res. 2007 May;32(5):399-405. doi: 10.1080/02713680701294723.
PubMed 17514524Marticorena J, Rodriguez-Ares MT, Tourino R, Mera P, Valladares MJ, Martinez-de-la-Casa JM, Benitez-del-Castillo JM. Pterygium surgery: conjunctival autograft using a fibrin adhesive. Cornea. 2006 Jan;25(1):34-6. doi: 10.1097/01.ico.0000164780.25914.0a.
PubMed 16331038
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia
- ClinicalTrials.gov ID
- NCT00949728
- Acronym / sponsor ID
- cola106
- Keywords
- Pterygium, Autologous Transplantation, Conjunctiva, Fibrin Tissue Adhesive, Recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Hospital de Olhos Sadalla Amin GhanemUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 30 Jul 2009 (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.
To evaluate the recurrence and postoperative complications rates after conjunctival autograft surgery using fibrin adhesive for primary pterygium
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibrin glue | Other | Procedure: Conjunctival autograft using fibrin glue |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of primary pterygium
- Symptomatic pterygium
- Limbal invasion
Key exclusion criteria (1 listed)
- Secondary pterygium
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 |
|---|---|---|
| Conjunctival autograft using fibrin glueAlso: Pterygium surgery using fibrin glueConjunctival autograft using fibrin glue in pterygium surgery | Procedure or surgery | Fibrin glue |
Primary outcome
Recurrence of pterygium after its excision with the conjunctival autograft technique.
Time frame: One, three and five months after surgery.
1 secondary outcome
Postoperative complications following the pterygium excision, such as partial graft detachment, dellen, granuloma or sutures failure.
Time frame: One day, one week and one month after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2009.
- Background: PubMed 15205236Koranyi G, Seregard S, Kopp ED. Cut and paste: a no suture, small incision approach to pterygium surgery. Br J Ophthalmol. 2004 Jul;88(7):911-4. doi: 10.1136/bjo.2003.032854.
- Background: PubMed 17514524Bahar I, Weinberger D, Gaton DD, Avisar R. Fibrin glue versus vicryl sutures for primary conjunctival closure in pterygium surgery: long-term results. Curr Eye Res. 2007 May;32(5):399-405. doi: 10.1080/02713680701294723.
- Background: PubMed 16331038Marticorena J, Rodriguez-Ares MT, Tourino R, Mera P, Valladares MJ, Martinez-de-la-Casa JM, Benitez-del-Castillo JM. Pterygium surgery: conjunctival autograft using a fibrin adhesive. Cornea. 2006 Jan;25(1):34-6. doi: 10.1097/01.ico.0000164780.25914.0a.
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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.
Renan F Oliveira principal investigator
Ramon C Ghanem, M.D. study director
Sadalla Amin Ghanem Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conjunctival autograft using fibrin glue in people with Pterygium and Primary, run by Hospital de Olhos Sadalla Amin Ghanem at 1 site in Brazil.
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 1 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: finished, as of the sponsor's last update on 30 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of pterygium after its excision with the conjunctival autograft technique. (time frame: One, three and five months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00949728, which also lists 3 linked publications.
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 30 Jul 2009.