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

Not Applicable

Completed

• Conditions: Pterygium of Both Eyes
• Interventions: Procedure: Amniotic membrane transplantation

• Registration Number: NCT04385446
• Lead Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-02-02
• Primary Completion: 2017-02-07
• Study Completion: 2018-09-05
• Status Verified: 2020-04
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-05-07
• Last Update Submitted: 2020-05-07
• Study First Posted: 2020-05-13
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Patients with nasal, primary pterygium bigger than 1 mm.

Exclusion Criteria

• Diabetes mellitus, single eye.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amniotic membrane transplantation	Amniotic membrane transplantation	Amniotic membrane transplantation was used as covering material in the area where the pterygium tissue was removed during the surgery.

Primary Outcome Measures

Name	Time	Method
Tear film breakup time.	The patients will be assed during six months	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.
Ocular tear film Mucin MUC2 concentration.	The patients will be assed during six months	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.
Ocular Tear film Mucin MUC5ac concentration.	The patients will be assed during six months	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.

Secondary Outcome Measures

Name	Time	Method
Pterygium recurrence.	The patients will be assed during six months	Pterygium recurrence was defined as any fibrovascular proliferation from the original pterygium site from it was surgically removed.