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

NCT04385446 | Completed

• 1 other identifier: CC-001/105
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pterygium of Both Eyes

Keywords

pterygium, amniotic membrane, conjunctival autograft, ocular mucin

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Pterygium recurrence.

  The patients will be assed during six months

Study Arms (2)

Amniotic membrane transplantation

ACTIVE COMPARATOR

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

Procedure: Amniotic membrane transplantation

conjnctival autograft.

NO INTERVENTION

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

Interventions

Amniotic membrane transplantation PROCEDURE

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

Amniotic membrane transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Diabetes mellitus, single eye.

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 groups

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 13, 2020
• Study Start: February 2, 2016
• Primary Completion: February 7, 2017
• Study Completion: September 5, 2018
• Last Updated: May 13, 2020

Record last verified: 2020-04