Determinants of Pterygium Occurrence and Recurrence in a Rural African Population
The aim of the study is to find out why pterygium occurs and recurs in a rural African population. Participants will be interviewed on personal and lifestyle information, family history of pterygium, environmental exposure and history of previous eye inflammation. They will undergo eye examination and photography. Those with pterygium will be operated on to remove pterygium and followed up to detect any recurrence and complications of surgery. The excised pterygium will be examined pathologically and genetically; participant's blood will also be examined genetically. Data will be analyzed for statistically significant differences in findings between pterygium and pterygium free participants.
The study hypothesis is that multiple factors are responsible for the occurrence and recurrence of pterygium in a rural african population.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Limpopo
-
Polokwane, Limpopo, Sydafrika, 0727
- Mankweng Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Pterygium at least 1.5mm in extent
- Both male and female
- Age range 21-65 years
- Consenting to participate in study
- Unilateral and bilateral pterygium
- All grades of pterygium
Exclusion Criteria:
- Previous cataract, corneoscleral and glaucoma surgery or corneoscleral trauma and corneolimbal scars
- Pseudopterygium or signs of malignancy on pterygium
- Recurrent pterygium
- Sufferers of collagen vascular disease, scleritis or diabetes -
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: 1
Pterygium free participants
|
|
|
Eksperimentel: 2
Pterygium participants
|
Pterygium will be excised followed by either free conjunctival or limbal conjunctival graft obtained from the upper part of the globe.
The graft will be kept in place by sutures
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
None recurrence of pterygium
Tidsramme: 6 months of follow up after operation
|
6 months of follow up after operation
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
corneal scarring
Tidsramme: 6 months of follow up
|
6 months of follow up
|
|
tenon's granuloma
Tidsramme: 6 months of follow up
|
6 months of follow up
|
|
graft retraction
Tidsramme: one month of follow up
|
one month of follow up
|
|
Graft haematoma
Tidsramme: one week of follow up
|
one week of follow up
|
|
Graft hyperaemia
Tidsramme: 3 months of follow up
|
3 months of follow up
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Peter Anguria, MMed, Mankweng Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Research laboratory
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