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

NCT ID: NCT04385446

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-02
• Study Completion Date: 2018-09-05

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.

Conditions

Pterygium of Both Eyes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Amniotic membrane transplantation

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

Group Type: ACTIVE_COMPARATOR

Amniotic membrane transplantation

Intervention Type: PROCEDURE

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

conjnctival autograft.

Conjunctival autograft was used as a covering material in the area where the pterygium tissue was removed during the surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Amniotic membrane transplantation

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Diabetes mellitus, single eye.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Oftalmología Fundación Conde de Valenciana

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CC-001/105

Identifier Type: -

Identifier Source: org_study_id