An interventional study of Amniotic membrane transplantation in Pterygium of Both Eyes, sponsored by Instituto de Oftalmología Fundación Conde de Valenciana. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-13.
Sponsored by Instituto de Oftalmología Fundación Conde de Valenciana · Not applicable, Interventional, and Screening
To identify and compare the differences in the concentration of the Muc2 and Muc5AC mucins in tear film in patients who underwent pterygium surgery using amniotic membrane transplantation and conjunctival autograft surgery.
Patients with nasal, primary pterygium bigger than 1 mm of corneal invasion with residence in Mexico City and older than 18 years were included. Under informed consent, patients were divided into two groups in a random fashion. Pterygium surgery was carried out with conventional technique performing amniotic membrane transplantation for group A, and conjunctival autograft for group B. Muc2 and muc5ac mucin concentration was measure min tear film by ELISA; samples were taken before surgery, at first, third and sixth month postoperatively. BUT was also measured on the same dates. Descriptive statistics and the U-Mann Whitney test for independent groups, considering a p≤0.05 as significant were used for analysis.
109 studies on the registry are indexed under Pterygium; 9 are open to participants now.
This study's enrollment of 44 is below the median of 60 across 93 interventional studies indexed under Pterygium.
Browse Pterygium studies →Instituto de Oftalmología Fundación Conde de Valenciana is the lead sponsor of 45 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Amniotic membrane transplantation was used as covering material in the area where the pterygium tissue was removed during the surgery.
Procedure: Amniotic membrane transplantation
Conjunctival autograft was used as a covering material in the area where the pterygium tissue was removed during the surgery.
Amniotic membrane transplantation was used as covering material during pterygium surgery.
Ocular Tear film Mucin MUC5ac concentration.
Using a capillary tube, tear film was collected en every patient. Then Concentration of mucin MUC5ac were measured by Elisa technique using a quantitative scale.
Time frame: The patients will be assed during six months
Ocular tear film Mucin MUC2 concentration.
Using a capillary tube, tear film was collected en every patient. Then Concentration of mucin MUC2 were measured by Elisa technique using a quantitative scale.
Time frame: The patients will be assed during six months
Tear film breakup time.
Tear film breakup time is the time between a complete blink and the appearance of the first random corneal dry spot and indicates relative tear film stability.
Time frame: The patients will be assed during six months
Pterygium recurrence.
Pterygium recurrence was defined as any fibrovascular proliferation from the original pterygium site from it was surgically removed.
Time frame: The patients will be assed during six months
No study locations are listed for this record.
Ran from Feb 2016 to primary completion in Feb 2017, 12 months.
Of 18 interventional studies with no phase under Pterygium, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 28. This study's 12 months is below that.
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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Instituto de Oftalmología Fundación Conde de Valenciana