Pterygium of Both EyesNCT04385446
Comparative Study of Muc5ac and Muc2 Mucins in Tear Film Concentration in Surgical Treated Pterygia Patients
A study testing Amniotic membrane transplantation in people with Pterygium of Both Eyes, run by Instituto de Oftalmología Fundación Conde de Valenciana.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pterygium of Both Eyes
- What is being tested?
- Amniotic membrane transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2016to 5 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with nasal, primary pterygium bigger than 1 mm.
Who cannot join
- Diabetes mellitus, single eye.
About this study
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
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.
Read the 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
- Being tested
- Amniotic membrane transplantation
- Keywords
- pterygium, amniotic membrane, conjunctival autograft, ocular mucin
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic membrane transplantationProcedure or surgery
Amniotic membrane transplantation was used as covering material during pterygium surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: The patients will be assed during six months
Secondary outcomes (1)
Pterygium recurrence.
Pterygium recurrence was defined as any fibrovascular proliferation from the original pterygium site from it was surgically removed.
Measured: The patients will be assed during six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start2 Feb 2016
- Primary completion7 Feb 2017
- Study completion5 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pterygium of Both EyesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385446
- Sponsor's protocol ID
- CC-001/105
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04385446
- Acronym / sponsor ID
- CC-001/105
- Conditions
- Pterygium of Both Eyes
- Keywords
- pterygium, amniotic membrane, conjunctival autograft, ocular mucin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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 groups
| Arm | Type | Receives |
|---|---|---|
| Amniotic membrane transplantation | Active comparator | Procedure: Amniotic membrane transplantationAmniotic membrane transplantation was used as covering material in the area where the pterygium tissue was removed during the surgery. |
| conjnctival autograft. | No intervention | –Conjunctival autograft was used as a covering material in the area where the pterygium tissue was removed during the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with nasal, primary pterygium bigger than 1 mm.
Key exclusion criteria (1 listed)
- Diabetes mellitus, single eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amniotic membrane transplantationAmniotic membrane transplantation was used as covering material during pterygium surgery. | Procedure or surgery | Amniotic membrane transplantation |
Primary outcome
Ocular Tear film Mucin MUC5ac concentration.
Time frame: 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.
Time frame: 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.
Time frame: 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.
1 secondary outcome
Pterygium recurrence.
Time frame: The patients will be assed during six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
Related trials for Pterygium of Both Eyes
Not yet recruiting
Clinical Outcomes of Sutured Versus Sutureless Conjunctival Autograft in Primary Pterygium Excision
Pterygium of Conjunctiva and Cornea, Pterygium of Both Eyes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Amniotic membrane transplantation in people with Pterygium of Both Eyes, run by Instituto de Oftalmología Fundación Conde de Valenciana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Tear film Mucin MUC5ac concentration. (time frame: The patients will be assed during six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.