The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: conjunctival autograft The conjunctival autograft was performed after the pterygium surgery like usual technique. |
Procedure: pterygium surgery
pterygium was removed surgically
Other Names:
|
| Experimental: latex biomembrane application 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. |
Procedure: pterygium surgery
pterygium was removed surgically
Other Names:
|
Outcome Measures
Primary Outcome Measures
- change in fibrovascular tissue growing measure [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.
Secondary Outcome Measures
- pterygium recurrence [twelve months]
Pterygium recurrence was defined like fibrovascular tissue growing up to 1,5mm across the anatomic limbus.
Eligibility Criteria
Criteria
Inclusion Criteria:
- symptomatic pterygium
Exclusion Criteria:
- any other ocular surface pathology, glaucoma, retinal disease, pregnancy, auto immune disease, severe systemic disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Erika Christina Canarim Martha de Pinho | Ribeirão Preto | SP | Brazil |
Sponsors and Collaborators
- University of Sao Paulo
Investigators
- Study Chair: Sidney JF Sousa, phD, Ribeirão Preto Faculty of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- Geggel HS, Friend J, Thoft RA. Conjunctival epithelial wound healing. Invest Ophthalmol Vis Sci. 1984 Jul;25(7):860-3.
- Pinho ECCM, Chahud F, Lachat JJ, Coutinho-Netto JJ, Sousa SJFE. The study of the use of a latex biomembrane and conjunctival autograft in rabbit conjunctiva wound healing. Arq Bras Oftalmol. 2018 Apr;81(2):125-129. doi: 10.5935/0004-2749.20180028.
- PINHO, 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.; 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.
- 12416/05