Depression - Major Depressive DisorderNCT07195721
The Effect of PROSE or Scleral Lenses on Mental Health
An observational study of Depression - Major Depressive Disorder, run by Boston Sight at 1 site in United States.
Trial summary
The goal of this prospective clinical trial is to evaluate the effect that prosthetic replacement of the ocular surface ecosystem (PROSE, BostonSight, Needham MA) treatment may have on mental health, particularly affective mood disorders. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depression - Major Depressive Disorder
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2024to 31 Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are being evaluated for PROSE or scleral lens treatment.
Who may be able to join
- Written Informed Consent has been obtained prior to any study-related procedures taking place.
- Subject is Male or Female, 18 years of age or older prior to the initial visit.
- Patient is proceeding with a PROSE or scleral lens consultation in one or both eyes for the primary diagnosis of ocular surface disease, including but not limited to Ocular Graft vs Host Disease, Keratoconjunctivitis Sicca, Dry eye, Sjogren's Disease, Rheumatologic ocular surface disease, Exposure Keratitis, Limbal Stem Cell Deficiency, Steven Johnson Syndrome, Mucous Membrane Pemphigoid (Ocular Cicatricial Pemphigoid), Atopic Keratoconjunctivitis, Chemical injury.
- Baseline PHQ-9 score > 4
- Baseline OSDI score of 13 or greater
- In the opinion of the investigator, the subject can follow study instructions, complete all study procedures and visits
- Is able to understand the English language in verbal and written interactions -
Who cannot join
- Is currently participating in any other type of eye-related clinical research study that in the opinion of the investigator would interfere with the study
- Is pregnant or nursing as reported by the subject.
- Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study.
- Recently started medication or other therapeutic treatments for affective mood disorders (such as depression) within the last 8 weeks.
- Recently started new treatment for ocular surface disease, including but not limited to topical medicated drops, procedures, punctal plugs within the last 8 weeks.
- Ocular surgery within the last 8 weeks
Show all 13Show fewer
- Planned ocular surgery within the study period
- Has a known allergy to topical ophthalmic sodium fluorescein dye
- Has a known intolerance to topical ophthalmic normal saline
- Neurotrophic Keratitis
- Corneal ectasia
- PROSE or scleral lens wearer within the last 1 year prior to Visit 1 [subjects who have solely tried a PROSE or scleral lens in an office setting consultation (and were never dispensed for home use) ARE eligible for enrollment, regardless of whether it occurred in the last year]
- Is an employee of BostonSight or an employee of a site performing the study -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
BostonSight
Needham, Massachusetts, 02494
Estelle Crowley, BS, 7817267506, ecrowley@bostonsight.org
dbrocks@bostonsight.org
About this study
Official title: The Effect of PROSE Treatment on Mental Health
The goal of this prospective clinical trial is to evaluate the effect that prosthetic replacement of the ocular surface ecosystem (PROSE, BostonSight, Needham MA) treatment may have on mental health, particularly affective mood disorders. Correlation between changes in mental health and ocular symptom improvement and/or visual function improvement will be evaluated.
Read the detailed description
PROSE treatment is an FDA approved iterative process which includes designing a highly customized rigid gas permeable scleral lens for the treatment of ocular surface disease (such as keratoconjunctivitis sicca, Sjogren's syndrome, ocular Graft versus Host Disease and cicatricial keratoconjunctivitis) in order to mitigate pain (often severe), prevent vision loss from ocular surface breakdown, scarring, ulceration, melt and perforation and to achieve best corrected visual acuity. PROSE achieves its therapeutic purpose by filling the device each day with preservative free normal saline in order to neutralize corneal irregularities and to provide constant lubrication and protection to the ocular surface. Associations between mental health and ocular disease have been described in literature, including irregular corneas and ocular surface pathology. Many of these conditions are associated with dry eye symptoms. Given the role of inflammation in the pathogenesis of dry eye disease (DED) and the bidirectional nature of depression and inflammation, it is unsurprising that multiple studies have demonstrated the positive association between DED and anxiety and depression.
In particular, there is a strong association that those with depression may be more likely to have severe DED symptoms, with some studies showing increased likelihood of DED in patients with depression by an odds ratio of 1.92. Although the literature is inconsistent in its findings of the association between depression and objective DED signs, multiple studies have reliably shown that there is close alignment between subjectively reported DED symptoms and depression.
Mental health associations have also been established with ocular Graft versus Host Disease (oGvHD) both through the relationship between oGvHD and dry eye syndrome and as demonstrated by higher scores on Visual Function Questionnaire 25 (VFQ-25), which correlate to worse mental health status.
Patients with oGvHD report limitations in daily and recreational activities with some patients experiencing pain so severe that they are unable to leave their homes. Anecdotally, in clinical care, improvement with affect and mood are reported following treatment of these debilitating diseases with PROSE.
This is believed to be relatable to improvement in ocular symptoms, including pain, as well as improvement in vision and daily functionality.
This study will investigate the possible correlation of improved mental health following medical intervention with PROSE. The investigators hypothesize that patients with ocular surface disease who undergo first-time intervention with PROSE will demonstrate an improvement in mental health as measured by the validated PHQ-9 questionnaire19-23 within a 6-month timeframe. Investigators will also assess the relationship between changes in PHQ-9 scoring and ocular symptoms, utilizing the validated Ocular Surface Disease Index (OSDI). Lastly, investigators will evaluate the relationship between changes in PHQ-9 scoring and quality of life and functionality, utilizing the VFQ-25.
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- PROSE - prosthetic replacement of the ocular surface ecosystem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who are considering PROSE treatment for ocular surface disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire 9 (PHQ9)
The nine-item Patient Health Questionnaire (PHQ-9) is a depressive symptom scale and diagnostic tool introduced in 2001 to screen adult patients in primary care settings. The instrument assesses for the presence and severity of depressive symptoms and a possible depressive disorder. The minimum score on the PHQ9 is 0 and the maximum score is 27 which indicates the most severe depression.
Measured: At enrollment, 28 days post PROSE dispense and 84 days post PROSE dispense
Secondary outcomes (2)
Ocular Surface Disease Index (OSDI) questionnaire
The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate,and severe) and effect on vision-related function. The minimum score on the OSZDZI is 0 and the maximum score is 100 which indicates greater disability dues to dry eye disease.
Measured: At enrollment, 28 days post PROSE dispense and 84 days post PROSE dispense
Visual Function Questionnaire 25 (VFQ25)
Measures the dimensions of self-reported vision-targeted health status that are most important for persons who have chronic eye diseases. The minimum score on the VFQ25 is 0 and the maximum score is 100 with higher scores indicating better visual function and health status.
Measured: At enrollment, 28 days post PROSE dispense and 84 days post PROSE dispense
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start11 Nov 2024
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Sight
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Brocks, MD, Principal investigator, Boston Sight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195721
- Sponsor's protocol ID
- MH-2024-DB
- Status last verified
- Oct 2025
- First submitted
- 25 Sep 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of PROSE Treatment on Mental Health
- ClinicalTrials.gov ID
- NCT07195721
- Acronym / sponsor ID
- MH-2024-DB
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- PROSE - prosthetic replacement of the ocular surface ecosystem
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Boston SightUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 29 Sep 2025 (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.
The goal of this prospective clinical trial is to evaluate the effect that prosthetic replacement of the ocular surface ecosystem (PROSE, BostonSight, Needham MA) treatment may have on mental health, particularly affective mood disorders. Correlation between changes in mental health and ocular symptom improvement and/or visual function improvement will be evaluated.
Detailed description
PROSE treatment is an FDA approved iterative process which includes designing a highly customized rigid gas permeable scleral lens for the treatment of ocular surface disease (such as keratoconjunctivitis sicca, Sjogren's syndrome, ocular Graft versus Host Disease and cicatricial keratoconjunctivitis) in order to mitigate pain (often severe), prevent vision loss from ocular surface breakdown, scarring, ulceration, melt and perforation and to achieve best corrected visual acuity. PROSE achieves its therapeutic purpose by filling the device each day with preservative free normal saline in order to neutralize corneal irregularities and to provide constant lubrication and protection to the ocular surface. Associations between mental health and ocular disease have been described in literature, including irregular corneas and ocular surface pathology. Many of these conditions are associated with dry eye symptoms. Given the role of inflammation in the pathogenesis of dry eye disease (DED) and the bidirectional nature of depression and inflammation, it is unsurprising that multiple studies have demonstrated the positive association between DED and anxiety and depression.
In particular, there is a strong association that those with depression may be more likely to have severe DED symptoms, with some studies showing increased likelihood of DED in patients with depression by an odds ratio of 1.92. Although the literature is inconsistent in its findings of the association between depression and objective DED signs, multiple studies have reliably shown that there is close alignment between subjectively reported DED symptoms and depression.
Mental health associations have also been established with ocular Graft versus Host Disease (oGvHD) both through the relationship between oGvHD and dry eye syndrome and as demonstrated by higher scores on Visual Function Questionnaire 25 (VFQ-25), which correlate to worse mental health status.
Patients with oGvHD report limitations in daily and recreational activities with some patients experiencing pain so severe that they are unable to leave their homes. Anecdotally, in clinical care, improvement with affect and mood are reported following treatment of these debilitating diseases with PROSE.
This is believed to be relatable to improvement in ocular symptoms, including pain, as well as improvement in vision and daily functionality.
This study will investigate the possible correlation of improved mental health following medical intervention with PROSE. The investigators hypothesize that patients with ocular surface disease who undergo first-time intervention with PROSE will demonstrate an improvement in mental health as measured by the validated PHQ-9 questionnaire19-23 within a 6-month timeframe. Investigators will also assess the relationship between changes in PHQ-9 scoring and ocular symptoms, utilizing the validated Ocular Surface Disease Index (OSDI). Lastly, investigators will evaluate the relationship between changes in PHQ-9 scoring and quality of life and functionality, utilizing the VFQ-25.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who are considering PROSE treatment for ocular surface disease | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are being evaluated for PROSE or scleral lens treatment.
Key inclusion criteria (7 listed)
- Written Informed Consent has been obtained prior to any study-related procedures taking place.
- Subject is Male or Female, 18 years of age or older prior to the initial visit.
- Patient is proceeding with a PROSE or scleral lens consultation in one or both eyes for the primary diagnosis of ocular surface disease, including but not limited to Ocular Graft vs Host Disease, Keratoconjunctivitis Sicca, Dry eye, Sjogren's Disease, Rheumatologic ocular surface disease, Exposure Keratitis, Limbal Stem Cell Deficiency, Steven Johnson Syndrome, Mucous Membrane Pemphigoid (Ocular Cicatricial Pemphigoid), Atopic Keratoconjunctivitis, Chemical injury.
- Baseline PHQ-9 score > 4
- Baseline OSDI score of 13 or greater
Key exclusion criteria (13 listed)
- Is currently participating in any other type of eye-related clinical research study that in the opinion of the investigator would interfere with the study
- Is pregnant or nursing as reported by the subject.
- Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study.
- Recently started medication or other therapeutic treatments for affective mood disorders (such as depression) within the last 8 weeks.
- Recently started new treatment for ocular surface disease, including but not limited to topical medicated drops, procedures, punctal plugs within the last 8 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Health Questionnaire 9 (PHQ9)
Time frame: At enrollment, 28 days post PROSE dispense and 84 days post PROSE dispense
The nine-item Patient Health Questionnaire (PHQ-9) is a depressive symptom scale and diagnostic tool introduced in 2001 to screen adult patients in primary care settings. The instrument assesses for the presence and severity of depressive symptoms and a possible depressive disorder. The minimum score on the PHQ9 is 0 and the maximum score is 27 which indicates the most severe depression.
2 secondary outcomes
Ocular Surface Disease Index (OSDI) questionnaire
Time frame: At enrollment, 28 days post PROSE dispense and 84 days post PROSE dispense
Visual Function Questionnaire 25 (VFQ25)
Time frame: At enrollment, 28 days post PROSE dispense and 84 days post PROSE dispense
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Daniel Brocks, MD principal investigator
Boston Sight
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 Depression - Major Depressive Disorder, run by Boston Sight at 1 site in United States.
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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 5 Jan 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Estelle Crowley, BS (17817267506, ecrowley@bostonsight.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire 9 (PHQ9) (time frame: At enrollment, 28 days post PROSE dispense and 84 days post PROSE dispense). 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 5 Jan 2026.