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

Pterygium of Both Eyes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385446
• Other study ID #: CC-001/105
• Status: Completed
• Phase: N/A
• Start date: February 2, 2016
• Est. completion date: September 5, 2018

Study information

• Verified date: April 2020
• Source: Instituto de Oftalmología Fundación Conde de Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 5, 2018
• Est. primary completion date: February 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Diabetes mellitus, single eye.

Related Conditions & MeSH terms

• Pterygium
• Pterygium of Both Eyes

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Oftalmología Fundación Conde de Valenciana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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