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Completed

NCT Number: NCT04385446

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

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.

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Key information

Conditions

Pterygium of Both Eyes Conjunctival Diseases Eye Diseases Pterygium

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Diabetes mellitus, single eye.

Treatment and study plan

Amniotic membrane transplantation

Procedure

Amniotic membrane transplantation was used as covering material during pterygium surgery.

Primary outcomes

  1. Ocular Tear film Mucin MUC5ac concentration.

    Time frame: 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.

  2. Ocular tear film Mucin MUC2 concentration.

    Time frame: 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.

  3. Tear film breakup time.

    Time frame: 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.

Secondary outcomes

  1. Pterygium recurrence.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 13, 2020
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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