Conjunctival DiseasesPhase 2NCT01250353
The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction
A Phase 2 study testing pterygium surgery in people with Conjunctival Diseases and Pterygium, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The main problem of ocular surface reconstruction is the lack of viable conjunctival tissue. The use of a biocompatible latex biomembrane in ocular surface healing, like post pterygium surgery, could be an alternative therapeutic resource to this process. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Conjunctival Diseases, Pterygium
- What is being tested?
- pterygium surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2006to Jul 2009
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic pterygium
Who cannot join
- any other ocular surface pathology, glaucoma, retinal disease, pregnancy, auto immune disease, severe systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction and Pterygium
The main problem of ocular surface reconstruction is the lack of viable conjunctival tissue. The use of a biocompatible latex biomembrane in ocular surface healing, like post pterygium surgery, could be an alternative therapeutic resource to this process.
Read the detailed description
The latex biomembrane is considered biocompatible and believed to promote neoformation of biological tissues. It also induces vascular neoformation and promotes extra cellular provisional matrix formation, fundamental steps for any kind of wound healing. In humans, it was successfully used in chronic cutaneous ulcer and otologic surgeries. In rabbits' eyes, the latex biomembrane was efficient in ocular surface reconstruction with adequate conjunctiva functional recovery, compared to bare sclera. To study the latex biomembrane action in human ocular surface, it was compared to conjunctival autograft in humans eyes. Considering the deficiency of adequate sized groups and the pterygium recurrences criteria differences, this study proposes the fibrovascular tissue growing measure like an auxiliary method of pos-operative evaluation. The biomembrane of natural latex seems to be efficient in ocular surface reconstruction and must be employed in future studies of other ocular pathologies. This material revealed to be a new source of therapeutic resort to external eye diseases and conjunctival replace in surgeries living bare sclera.
- Conditions
- Conjunctival Diseases, Pterygium
- Being tested
- pterygium surgery
- Keywords
- ocular surface reconstruction, conjunctival healing, pterygium, latex biomembrane, pterygium surgery
- Medical subject headings
- Conjunctival Diseases, Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pterygium surgeryProcedure or surgery
Also called pterygium excision, prevention of pterygium recurrence
pterygium was removed surgically
| Study group | Role | What they receive |
|---|---|---|
| conjunctival autograft | Experimental | The conjunctival autograft was performed after the pterygium surgery like usual technique. Receives: Procedure: pterygium surgery |
| latex biomembrane application | Experimental | The latex biomembrane was applied after pterygium surgery to recover the bare sclera area. This device was closed to conjunctiva with running suture anchored at some places to episclera. The sutures was removed at fourteenth day after surgery. Receives: Procedure: pterygium surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in fibrovascular tissue growing measure
The fibrovascular tissue growing measure was designed to be an auxiliary method of pos-operative evaluation. At the slit lamp, the pterygium or the fibrovascular growing tissue was measured related to anatomic limbus. To the scleral side was given negative value and to the cornea side was given positive value. The anatomic limbus was the zero in this scale. The results were compared at inicial stage and three, six and twelve months, to evaluate the progression and recurrence probability.
Measured: twelve months
Secondary outcomes (1)
pterygium recurrence
Pterygium recurrence was defined like fibrovascular tissue growing up to 1,5mm across the anatomic limbus.
Measured: twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startJun 2006
- Primary completionJun 2007
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Conjunctival DiseasesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Sidney JF Sousa, phD, Study chair, Ribeirão Preto Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250353
- Sponsor's protocol ID
- 12416/05
- Status last verified
- Dec 2009
- First submitted
- 24 Nov 2010
- Last updated
- 30 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Geggel HS, Friend J, Thoft RA. Conjunctival epithelial wound healing. Invest Ophthalmol Vis Sci. 1984 Jul;25(7):860-3.
PubMed 6735650PINHO, E.C.C.M. Uso de uma membrana derivada de látex natural na superfície ocular. Estudo experimental em coelhos. Dissertação. (Mestrado em Oftalmolgia). Ribeirão Preto, Universidade de São Paulo, 2003. p 96.
PINHO, E.C.C.M.; FARIA E SOUSA, S.J.; CHAHUD, F.; LACHAT, J-J.; COUTINHO - NETTO, J. Uso experimental da biomembrana de látex na reconstrução conjuntival. Arquivos Brasileiros de Oftalmologia, v. 67, p. 27- 32, 2004.
PINHO, E.C.C.M.; SEIXAS, G.C.O.; SOUZA-JUNIOR, E.N.; FARIA E SOUSA, S.J.; LACHAT, J-J.; COUTINHO - NETTO, J. The use of natural latex in human eye: technique description. In: Congresso Mundial de Oftalmologia, 2006a, São Paulo. Anais eletrônicos, código 2717.
PINHO, E.C.C.M; FARIA E SOUSA, S.J.; SOUZA-JUNIOR, E.N.; SEIXAS, G.C.O.; LACHAT, J-J.; COUTINHO - NETTO, J. The use of natural latex in ocular surface, like tissue repair promoter, in pterygium excision. In: Congresso Mundial de Oftalmologia, 2006b, São Paulo. Anais eletrônicos, código 2150.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction and Pterygium
- ClinicalTrials.gov ID
- NCT01250353
- Acronym / sponsor ID
- 12416/05
- Conditions
- Conjunctival Diseases, Pterygium
- Keywords
- ocular surface reconstruction, conjunctival healing, pterygium, latex biomembrane, pterygium surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 30 Nov 2010 (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.
The main problem of ocular surface reconstruction is the lack of viable conjunctival tissue. The use of a biocompatible latex biomembrane in ocular surface healing, like post pterygium surgery, could be an alternative therapeutic resource to this process.
Detailed description
The latex biomembrane is considered biocompatible and believed to promote neoformation of biological tissues. It also induces vascular neoformation and promotes extra cellular provisional matrix formation, fundamental steps for any kind of wound healing. In humans, it was successfully used in chronic cutaneous ulcer and otologic surgeries. In rabbits' eyes, the latex biomembrane was efficient in ocular surface reconstruction with adequate conjunctiva functional recovery, compared to bare sclera. To study the latex biomembrane action in human ocular surface, it was compared to conjunctival autograft in humans eyes. Considering the deficiency of adequate sized groups and the pterygium recurrences criteria differences, this study proposes the fibrovascular tissue growing measure like an auxiliary method of pos-operative evaluation. The biomembrane of natural latex seems to be efficient in ocular surface reconstruction and must be employed in future studies of other ocular pathologies. This material revealed to be a new source of therapeutic resort to external eye diseases and conjunctival replace in surgeries living bare sclera.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conjunctival autograft | Experimental | Procedure: pterygium surgeryThe conjunctival autograft was performed after the pterygium surgery like usual technique. |
| latex biomembrane application | Experimental | Procedure: pterygium surgeryThe latex biomembrane was applied after pterygium surgery to recover the bare sclera area. This device was closed to conjunctiva with running suture anchored at some places to episclera. The sutures was removed at fourteenth day after surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- symptomatic pterygium
Key exclusion criteria (1 listed)
- any other ocular surface pathology, glaucoma, retinal disease, pregnancy, auto immune disease, severe systemic disease
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 surgeryAlso: pterygium excision, prevention of pterygium recurrencepterygium was removed surgically | Procedure or surgery | conjunctival autograft, latex biomembrane application |
Primary outcome
change in fibrovascular tissue growing measure
Time frame: twelve months
The fibrovascular tissue growing measure was designed to be an auxiliary method of pos-operative evaluation. At the slit lamp, the pterygium or the fibrovascular growing tissue was measured related to anatomic limbus. To the scleral side was given negative value and to the cornea side was given positive value. The anatomic limbus was the zero in this scale. The results were compared at inicial stage and three, six and twelve months, to evaluate the progression and recurrence probability.
1 secondary outcome
pterygium recurrence
Time frame: twelve months
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 Nov 2010.
- Background: PubMed 6735650Geggel HS, Friend J, Thoft RA. Conjunctival epithelial wound healing. Invest Ophthalmol Vis Sci. 1984 Jul;25(7):860-3.
- BackgroundPINHO, E.C.C.M. Uso de uma membrana derivada de látex natural na superfície ocular. Estudo experimental em coelhos. Dissertação. (Mestrado em Oftalmolgia). Ribeirão Preto, Universidade de São Paulo, 2003. p 96.
- BackgroundPINHO, E.C.C.M.; FARIA E SOUSA, S.J.; CHAHUD, F.; LACHAT, J-J.; COUTINHO - NETTO, J. Uso experimental da biomembrana de látex na reconstrução conjuntival. Arquivos Brasileiros de Oftalmologia, v. 67, p. 27- 32, 2004.
- BackgroundPINHO, E.C.C.M.; SEIXAS, G.C.O.; SOUZA-JUNIOR, E.N.; FARIA E SOUSA, S.J.; LACHAT, J-J.; COUTINHO - NETTO, J. The use of natural latex in human eye: technique description. In: Congresso Mundial de Oftalmologia, 2006a, São Paulo. Anais eletrônicos, código 2717.
- BackgroundPINHO, E.C.C.M; FARIA E SOUSA, S.J.; SOUZA-JUNIOR, E.N.; SEIXAS, G.C.O.; LACHAT, J-J.; COUTINHO - NETTO, J. The use of natural latex in ocular surface, like tissue repair promoter, in pterygium excision. In: Congresso Mundial de Oftalmologia, 2006b, São Paulo. Anais eletrônicos, código 2150.
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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.
Sidney JF Sousa, phD study chair
Ribeirão Preto Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pterygium surgery in people with Conjunctival Diseases and Pterygium, run by University of Sao Paulo 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 1 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 Nov 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change in fibrovascular tissue growing measure (time frame: twelve months). 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 NCT01250353, which also lists 5 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 Nov 2010.