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

I

Instituto de Oftalmología Fundación Conde de Valenciana

Status

Completed

Conditions

Pterygium of Both Eyes

Treatments

Procedure: Amniotic membrane transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT04385446
CC-001/105

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Diabetes mellitus, single eye.

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

44 participants in 2 patient groups

Amniotic membrane transplantation
Active Comparator group
Description:
Amniotic membrane transplantation was used as covering material in the area where the pterygium tissue was removed during the surgery.
Treatment:
Procedure: Amniotic membrane transplantation
conjnctival autograft.
No Intervention group
Description:
Conjunctival autograft was used as a covering material in the area where the pterygium tissue was removed during the surgery.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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