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

May 7, 2020 updated by: Instituto de Oftalmología Fundación Conde de Valenciana

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetes mellitus, single eye.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Amniotic membrane transplantation
Amniotic membrane transplantation was used as covering material in the area where the pterygium tissue was removed during the surgery.
Procedure: Amniotic membrane transplantation
Amniotic membrane transplantation was used as covering material during pterygium surgery.
NO_INTERVENTION: conjnctival autograft.
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?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 2, 2016

Primary Completion (ACTUAL)

February 7, 2017

Study Completion (ACTUAL)

September 5, 2018

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (ACTUAL)

May 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-001/105

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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