Comparative Study of Muc5ac and Muc2 Mucins in Tear Film Concentration in Surgical Treated Pterygia Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative Study of Concentration of Muc5ac and Muc2 Mucins in Tear Film in Surgical Treated Pterygia With Amniotic Membrane Transplantation vs. Conjunctival Autograft

Conditions
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Pterygium of Both Eyes

Intervention / Treatment
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* Procedure: Amniotic membrane transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with nasal, primary pterygium bigger than 1 mm. Exclusion Criteria: Diabetes mellitus, single eye.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups of patients in whom Conventional Pterygium surgery was performed Each patient was randomly assigned for either received amniotic membrane transplantation or conjunctival autograft as a recovering method in the pterygium removed area after surgery. Tear film Mucins were measured in both groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amniotic membrane transplantation<br>Amniotic membrane transplantation was used as covering material in the area where the pterygium tissue was removed during the surgery. | Procedure: Amniotic membrane transplantation<br>* Amniotic membrane transplantation was used as covering material during pterygium surgery.<br>|
| No Intervention: conjnctival autograft.<br>Conjunctival autograft was used as a covering material in the area where the pterygium tissue was removed during the surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | The patients will be assed during six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pterygium recurrence. | Pterygium recurrence was defined as any fibrovascular proliferation from the original pterygium site from it was surgically removed. | The patients will be assed during six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pterygium, amniotic membrane, conjunctival autograft, ocular mucin