Dry EyeMGPRONCT07621952
Meibomian Gland Changes in Ocular Prosthesis Users
An observational study of Dry Eye and Meibomian Gland Dysfunction (Disorder), run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial summary
This observational cross-sectional study aims to evaluate meibomian gland loss and dry eye symptoms in patients using unilateral ocular prostheses. The study compares the prosthetic eye with the contralateral healthy eye using the DEQ-5 questionnaire and meibography obtained with the Oculus Keratograph 5M. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Meibomian Gland Dysfunction (Disorder), Anophthalmic Socket Syndrome
- What is being tested?
- Oculus Keratograph 5M
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 18 Aug 2023to 26 Jul 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with unilateral ocular prostheses evaluated at the Oculoplastic Department of the Instituto de Oftalmología Fundación Conde de Valenciana, Mexico City, Mexico. Participants had a history of enucleation or evisceration and at least 6 months of ocular prosthesis use.
Who may be able to join
- Adults aged 18 years or older
- History of unilateral enucleation or evisceration
- Use of an ocular prosthesis for at least 6 months
- No use of topical ophthalmic medications within 1 month prior to evaluation
- Ability to complete ocular surface evaluation and questionnaires
Who cannot join
- Presence of orbital cavity infection
- Bilateral ocular prosthesis users
- Presence of ectropion or entropion
- Autoimmune diseases associated with ocular surface alterations
Trial locations and contacts
1 site in 1 country.
Mexico1 site
✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP
Mexico City, 06800
About this study
Official title: Evaluation of Meibomian Gland Loss and Dry Eye Symptoms in Ocular Prosthesis Users
This observational cross-sectional study aims to evaluate meibomian gland loss and dry eye symptoms in patients using unilateral ocular prostheses. The study compares the prosthetic eye with the contralateral healthy eye using the DEQ-5 questionnaire and meibography obtained with the Oculus Keratograph 5M. Additional ocular surface parameters, including conjunctival hyperemia and tear meniscus height, are also evaluated. The objective is to determine whether ocular prosthesis wear is associated with morphological changes in the meibomian glands and increased dry eye symptoms.
Read the detailed description
Loss of the eyeball and subsequent use of ocular prostheses have been associated with symptoms such as dryness, irritation, mucoid discharge, conjunctival hyperemia, and ocular discomfort. Meibomian gland dysfunction has been proposed as one of the mechanisms contributing to evaporative dry eye in anophthalmic socket patients. Chronic mechanical friction between the prosthesis and the tarsal conjunctiva, inflammation, and alterations of the ocular surface may induce glandular obstruction and atrophy.
This observational cross-sectional study evaluates morphological changes of the meibomian glands and dry eye symptoms in patients using unilateral ocular prostheses treated at the Oculoplastic Department of the Instituto de Oftalmología Fundación Conde de Valenciana, Mexico City, Mexico.
Adult patients with a history of enucleation or evisceration and at least 6 months of ocular prosthesis use are included. Each participant serves as their own control by comparing the prosthetic eye with the contralateral healthy eye.
Dry eye symptoms are assessed using the Dry Eye Questionnaire-5 (DEQ-5). Meibomian gland morphology, conjunctival hyperemia, and tear meniscus height are evaluated using the Oculus Keratograph 5M.
The primary objective is to determine the association between ocular prosthesis wear and meibomian gland loss. Secondary objectives include evaluating the association between prosthesis use and dry eye symptoms, conjunctival hyperemia, and tear meniscus alterations. The study also explores possible associations between prosthesis cleaning habits, duration of prosthesis use, and ocular surface findings.
- Conditions
- Dry Eye, Meibomian Gland Dysfunction (Disorder), Anophthalmic Socket Syndrome, Ocular Prostheses
- Being tested
- Oculus Keratograph 5M
- Keywords
- dry eye, Ocular Prostheses, tear film, Meibography, Meibomian Gland Dysfunction, Anophthalmic Socket
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oculus Keratograph 5MDiagnostic test
Dry Eye Questionnaire-5 used to assess dry eye symptoms in prosthetic and healthy eyes.
| Study group | Role | What they receive |
|---|---|---|
| Prosthetic Eye | Eyes with ocular prostheses in patients with unilateral anophthalmic socket. Meibomian gland morphology, dry eye symptoms, conjunctival hyperemia, and tear meniscus height were evaluated. Receives: Diagnostic Test: Oculus Keratograph 5M | |
| Healthy Contralateral Eye | Contralateral healthy eyes of the same patients used as controls for comparison of ocular surface and meibomian gland findings. Receives: Diagnostic Test: Oculus Keratograph 5M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meibomian Gland Loss
Meibomian gland loss in the upper eyelid assessed by meibography using the Oculus Keratograph 5M and compared between prosthetic eyes and contralateral healthy eyes.
Measured: At baseline
Secondary outcomes (2)
Dry Eye Symptoms
Dry eye symptoms assessed using the Dry Eye Questionnaire-5 (DEQ-5) and compared between prosthetic eyes and contralateral healthy eyes.
Measured: At baseline
Conjunctival Hyperemia
Conjunctival hyperemia assessed using the Jenvis grading scale with the Oculus Keratograph 5M and compared between prosthetic eyes and contralateral healthy eyes.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start18 Aug 2023
- Primary completion25 Jul 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 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
- NCT07621952
- Sponsor's protocol ID
- FCV-MGL-2023-01
- Acronym
- MGPRO
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Meibomian Gland Loss and Dry Eye Symptoms in Ocular Prosthesis Users
- ClinicalTrials.gov ID
- NCT07621952
- Acronym / sponsor ID
- MGPRO / FCV-MGL-2023-01
- Conditions
- Dry Eye, Meibomian Gland Dysfunction (Disorder), Anophthalmic Socket Syndrome, Ocular Prostheses
- Keywords
- dry eye, Ocular Prostheses, tear film, Meibography, Meibomian Gland Dysfunction, Anophthalmic Socket
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 2 Jun 2026 (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.
This observational cross-sectional study aims to evaluate meibomian gland loss and dry eye symptoms in patients using unilateral ocular prostheses. The study compares the prosthetic eye with the contralateral healthy eye using the DEQ-5 questionnaire and meibography obtained with the Oculus Keratograph 5M. Additional ocular surface parameters, including conjunctival hyperemia and tear meniscus height, are also evaluated. The objective is to determine whether ocular prosthesis wear is associated with morphological changes in the meibomian glands and increased dry eye symptoms.
Detailed description
Loss of the eyeball and subsequent use of ocular prostheses have been associated with symptoms such as dryness, irritation, mucoid discharge, conjunctival hyperemia, and ocular discomfort. Meibomian gland dysfunction has been proposed as one of the mechanisms contributing to evaporative dry eye in anophthalmic socket patients. Chronic mechanical friction between the prosthesis and the tarsal conjunctiva, inflammation, and alterations of the ocular surface may induce glandular obstruction and atrophy.
This observational cross-sectional study evaluates morphological changes of the meibomian glands and dry eye symptoms in patients using unilateral ocular prostheses treated at the Oculoplastic Department of the Instituto de Oftalmología Fundación Conde de Valenciana, Mexico City, Mexico.
Adult patients with a history of enucleation or evisceration and at least 6 months of ocular prosthesis use are included. Each participant serves as their own control by comparing the prosthetic eye with the contralateral healthy eye.
Dry eye symptoms are assessed using the Dry Eye Questionnaire-5 (DEQ-5). Meibomian gland morphology, conjunctival hyperemia, and tear meniscus height are evaluated using the Oculus Keratograph 5M.
The primary objective is to determine the association between ocular prosthesis wear and meibomian gland loss. Secondary objectives include evaluating the association between prosthesis use and dry eye symptoms, conjunctival hyperemia, and tear meniscus alterations. The study also explores possible associations between prosthesis cleaning habits, duration of prosthesis use, and ocular surface findings.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prosthetic Eye | – | Diagnostic Test: Oculus Keratograph 5MEyes with ocular prostheses in patients with unilateral anophthalmic socket. Meibomian gland morphology, dry eye symptoms, conjunctival hyperemia, and tear meniscus height were evaluated. |
| Healthy Contralateral Eye | – | Diagnostic Test: Oculus Keratograph 5MContralateral healthy eyes of the same patients used as controls for comparison of ocular surface and meibomian gland findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with unilateral ocular prostheses evaluated at the Oculoplastic Department of the Instituto de Oftalmología Fundación Conde de Valenciana, Mexico City, Mexico. Participants had a history of enucleation or evisceration and at least 6 months of ocular prosthesis use.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older
- History of unilateral enucleation or evisceration
- Use of an ocular prosthesis for at least 6 months
- No use of topical ophthalmic medications within 1 month prior to evaluation
- Ability to complete ocular surface evaluation and questionnaires
Key exclusion criteria (4 listed)
- Presence of orbital cavity infection
- Bilateral ocular prosthesis users
- Presence of ectropion or entropion
- Autoimmune diseases associated with ocular surface alterations
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 |
|---|---|---|
| Oculus Keratograph 5MDry Eye Questionnaire-5 used to assess dry eye symptoms in prosthetic and healthy eyes. | Diagnostic test | Healthy Contralateral Eye, Prosthetic Eye |
Primary outcome
Meibomian Gland Loss
Time frame: At baseline
Meibomian gland loss in the upper eyelid assessed by meibography using the Oculus Keratograph 5M and compared between prosthetic eyes and contralateral healthy eyes.
2 secondary outcomes
Dry Eye Symptoms
Time frame: At baseline
Conjunctival Hyperemia
Time frame: At baseline
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 2 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye and Meibomian Gland Dysfunction (Disorder), run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
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 5 inclusion and 4 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 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Meibomian Gland Loss (time frame: At baseline). 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 2 Jun 2026.