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

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana (Other)

Overall Status

Completed

CT.gov ID

NCT04385446

Collaborator

(none)

Enrollment

Arms

31.1

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pterygium of Both Eyes	Procedure: Amniotic membrane transplantation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 groupsTwo 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 (Participant, Outcomes Assessor)

Masking Description:

The patients did not know what kind of material was used in their surgery. The assessor who performed tear film analysis did not know what material was used in the patient.

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Feb 2, 2016

Actual Primary Completion Date :

Feb 7, 2017

Actual Study Completion Date :

Sep 5, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients with nasal, primary pterygium bigger than 1 mm.

Exclusion Criteria:

Diabetes mellitus, single eye.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Instituto de Oftalmología Fundación Conde de Valenciana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Instituto de Oftalmología Fundación Conde de Valenciana

ClinicalTrials.gov Identifier:

NCT04385446

Other Study ID Numbers:

CC-001/105

First Posted:

May 13, 2020

Last Update Posted:

May 13, 2020

Last Verified:

Apr 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Instituto de Oftalmología Fundación Conde de Valenciana

pterygium, amniotic membrane, conjunctival autograft, ocular mucin

Additional relevant MeSH terms:

Pterygium

Study Results

No Results Posted as of May 13, 2020