Dry EyeNCT04425551
Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction
A study testing laser light in people with Dry Eye and Dry Eye Syndromes, run by Naval Hospital, Athens at 2 sites in Greece.
Trial summary
The modern treatment of meibomian gland dysfunction(MGD) is based on anti-inflammatory drops or oral antibiotics for decreasing dry eye disease (DED) associated inflammation, warm compresses for liquefying the thicker meibum, and lid hygiene for reducing the bacterial overload. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Dry Eye Syndromes, Meibomian Gland Dysfunction
- What is being tested?
- laser light
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesGreece
- Study dates
- 6 Dec 2022to 18 Jul 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chief complaint of at least one of the following symptoms: dryness, foreign-body sensation, burning, and tearing for 3 months
- diagnosis of DED secondary to MGD with eyelid margin telangiectasias in both eyes
- a baseline Ocular Surface Disease Index (OSDI) score ≥ 40
- tear break-up time (TBUT) ≤ 5 seconds
- corneal fluorescein staining ≥ 6 as per the National Eye Institute (NEI) grading scale for corneal staining.
Who cannot join
- history of ocular trauma or surgery
- use of any treatment for DED or MGD other than artificial tears within the past 3 months
- active allergy, infection, or inflammatory disease at the ocular surface unrelated to DED or MGD
- lacrimal drainage system anomalies
- contact lens wear
- use of any systemic or topical anti-inflammatory medicine
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Naval Hospital of Athens
Athens, 11521
First Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece
Athens
About this study
Official title: Prospective Study of the Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction
The modern treatment of meibomian gland dysfunction(MGD) is based on anti-inflammatory drops or oral antibiotics for decreasing dry eye disease (DED) associated inflammation, warm compresses for liquefying the thicker meibum, and lid hygiene for reducing the bacterial overload. But, such treatments have shown limited effectiveness to a large proportion of patients with MGD, due to the multifactorial background of the disease. Thus, alternative approaches aiming at different aspects of the DED pathophysiology are needed.
Elimination of posterior lid-margin hyperemia with telangiectasia could be a treatment target for reducing the secretion of inflammatory mediators in the course of MGD. Using the mechanism of photocoagulation via selective thermolysis, laser light could contribute to the destruction of abnormal vessels at the posterior lid-margin and thus, the reduction of inflammation. Recently, sub-threshold (micropulse) laser photocoagulation was introduced in ophthalmology and offers significant clinical advantages compared to conventional continuous wave (CW) approach, preventing laser induced thermal damage and related treatment side effects.
This study investigates the effect of sub-threshold (micropulse) laser treatment for dry eye disease due to meibomian gland dysfunction combined with increased eyelid margin vascularity.
- Conditions
- Dry Eye, Dry Eye Syndromes, Meibomian Gland Dysfunction
- Being tested
- laser light, Sham treatment
- Keywords
- dry eye, meibomian gland dysfunction, subthreshold laser, telangiectasia, eyelid margin vascularity
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction, Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser lightProcedure or surgery
laser photocoagulation of the telangiectatic vessels of the lower eyelid margin with a slit lamp-based 532 nm optically pumped dual- diode solid-state subthreshold (SP-Mode) laser system
Sham treatmentDevice
Sham treatment replicated all procedural steps (eyelid eversion, stabilization, slit-lamp aiming, equivalent spot count) using identical laser settings, but with minimal power (50 mW, duration 10 ms) and beam offset to the adjacent non-vascular periorbital skin, ensuring no energy delivery to eyelid margin vessels, and preserving the device operational sound, laser light, and foot pedal activation. No laser energy was delivered to eyelid margin vasculature in the sham treatment, and no visible tissue reaction or blanching was observed during the procedure. The anesthesia and cleaning procedures were identical.
| Study group | Role | What they receive |
|---|---|---|
| Laser Group | Active comparator | The treatment involved laser photocoagulation of the telangiectatic vessels of the lower eyelid margin with a slit lamp-based 532 nm optically pumped dual- diode solid-state subthreshold (SP-Mode) laser system (LightLas TruScan Pro 532 nm, LightMed Corporation, San Clemente, CA, USA). The laser settings were selected to induce vascular photocoagulation without visible tissue blanching or epithelial disruption. The subthreshold treatment parameters were set at 50 μm spot size and duration of 200 ms with duty cycle of 20%. Laser power was titrated in mono-spot micropulse mode starting at 500 mW and increased in 100 mW steps, until focal blanching without epithelial whitening, maximum 1500 mW. The treatment endpoint was defined as immediate focal blanching (disappearance of the red reflex) of the target telangiectatic vessel, assessed under a high-magnification slit-lamp view, with the effect confined to the targeted vessel and no visible impact on adjacent tissue. Receives: Procedure: laser light |
| Control Group | Placebo comparator | Sham treatment replicated all procedural steps (eyelid eversion, stabilization, slit-lamp aiming, equivalent spot count) using identical laser settings, but with minimal power (50 mW, duration 10 ms) and beam offset to the adjacent non-vascular periorbital skin, ensuring no energy delivery to eyelid margin vessels, and preserving the device operational sound, laser light, and foot pedal activation. No laser energy was delivered to eyelid margin vasculature in the sham treatment, and no visible tissue reaction or blanching was observed during the procedure. The anesthesia and cleaning procedures were identical. Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Break Up Time (TBUT)
Using a slit-lamp biomicroscope with cobalt blue illumination, the time interval between the last complete blink and first appearance of a dark dry spot on the corneal surface was measured using a digital stopwatch. The test was repeated three times consecutively, and the mean TBUT was recorded
Measured: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
Secondary outcomes (11)
Ocular Surface Disease Index (OSDI)
The scoring system ranges from 0 to 100 and categorizes the ocular surface condition into normal (0-12), mild (13-22), moderate (23-32), or severe dry eye (≥ 33).15 OSDI questionnaire was administered once per patient to assess subjective symptom severity at each visit, whereas all other parameters were evaluated separately for each eye.
Measured: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
Lower Eyelid Tear Meniscus Height
height (μm) via Anterior Segment Swept-Source Optical Coherence Tomography
Measured: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
Lower Eyelid Tear Meniscus Depth
depth (μm) via Anterior Segment Swept-Source Optical Coherence Tomography
Measured: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
Meibomography
scale (0,1,2,3). Higher values represent greater disability.
Measured: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
Best Corrected Visual Acuity (BCVA)
using Snellen charts, which was converted to logMAR values for statistical analysis purposes.
Measured: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively
Schirmer test
under topical anesthesia standardized Schirmer strips were gently inserted into the lateral third of the lower eyelid margin, and the length of wetting (in millimeters) on the strip was recorded after 5 minutes
Measured: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
Eyelid margin vascularity
via slit-lamp biomicroscopy and graded on a 4-point scale as 0 (no visible telangiectasia), 1 (mild telangiectasia with few dilated vessels), 2 (moderate telangiectasia with several visible vessels), and 3 (severe telangiectasia with numerous engorged vessels and marked redness).
Measured: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
corneal staining and the conjunctival injection
using fluorescein dye, according to the National Eye Institute (NEI) scale
Measured: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively
Conjunctivochalasis
graded by the number and height of conjunctival folds using a slit lamp as 0 (no persistent folds), 1 (one small fold), 2 (two or more folds not higher than the tear meniscus), and 3 (multiple folds higher than the tear meniscus)
Measured: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
Meibomian gland (MG) expressibility
by applying standardized digital pressure to the central third of the lower lid, graded as 1 (light), 2 (moderate), or 3 (heavy pressure required).
Measured: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
secretion quality
0 (clear), 1 (cloudy), 2 (granular), or 3 (toothpaste-like).
Measured: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start6 Dec 2022
- Primary completion3 Apr 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Please note that there was one group of participants, but two groups of eyes (treated/untreated). Thus, PARALLEL was selected, referring to eyes, not participants
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naval Hospital, Athens
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Responsible party
- Principal investigator, Nikolaos Kappos, Naval Hospital, Athens
- Investigators
- Nikolaos Kappos, MD, Principal investigator, Naval Hospital, Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425551
- Sponsor's protocol ID
- 6/19
- Status last verified
- Dec 2025
- First submitted
- 4 Jun 2020
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kappos N, Georgalas I, Papaconstantinou D, Droutsas K. Focal Subthreshold Laser Photocoagulation of Eyelid Margin Vascularity in Telangiectatic Meibomian Gland Dysfunction. Cornea. 2026 Apr 7. doi: 10.1097/ICO.0000000000004161. Online ahead of print.
PubMed 41960977
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT04425551
- Acronym / sponsor ID
- 6/19
- Conditions
- Dry Eye, Dry Eye Syndromes, Meibomian Gland Dysfunction
- Keywords
- dry eye, meibomian gland dysfunction, subthreshold laser, telangiectasia, eyelid margin vascularity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Naval Hospital, AthensUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 11 Jun 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.
The modern treatment of meibomian gland dysfunction(MGD) is based on anti-inflammatory drops or oral antibiotics for decreasing dry eye disease (DED) associated inflammation, warm compresses for liquefying the thicker meibum, and lid hygiene for reducing the bacterial overload. But, such treatments have shown limited effectiveness to a large proportion of patients with MGD, due to the multifactorial background of the disease. Thus, alternative approaches aiming at different aspects of the DED pathophysiology are needed.
Elimination of posterior lid-margin hyperemia with telangiectasia could be a treatment target for reducing the secretion of inflammatory mediators in the course of MGD. Using the mechanism of photocoagulation via selective thermolysis, laser light could contribute to the destruction of abnormal vessels at the posterior lid-margin and thus, the reduction of inflammation. Recently, sub-threshold (micropulse) laser photocoagulation was introduced in ophthalmology and offers significant clinical advantages compared to conventional continuous wave (CW) approach, preventing laser induced thermal damage and related treatment side effects.
This study investigates the effect of sub-threshold (micropulse) laser treatment for dry eye disease due to meibomian gland dysfunction combined with increased eyelid margin vascularity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Please note that there was one group of participants, but two groups of eyes (treated/untreated). Thus, PARALLEL was selected, referring to eyes, not participants
| Arm | Type | Receives |
|---|---|---|
| Laser Group | Active comparator | Procedure: laser lightThe treatment involved laser photocoagulation of the telangiectatic vessels of the lower eyelid margin with a slit lamp-based 532 nm optically pumped dual- diode solid-state subthreshold (SP-Mode) laser system (LightLas TruScan Pro 532 nm, LightMed Corporation, San Clemente, CA, USA). The laser settings were selected to induce vascular photocoagulation without visible tissue blanching or epithelial disruption. The subthreshold treatment parameters were set at 50 μm spot size and duration of 200 ms with duty cycle of 20%. Laser power was titrated in mono-spot micropulse mode starting at 500 mW and increased in 100 mW steps, until focal blanching without epithelial whitening, maximum 1500 mW. The treatment endpoint was defined as immediate focal blanching (disappearance of the red reflex) of the target telangiectatic vessel, assessed under a high-magnification slit-lamp view, with the effect confined to the targeted vessel and no visible impact on adjacent tissue. |
| Control Group | Placebo comparator | Device: Sham treatmentSham treatment replicated all procedural steps (eyelid eversion, stabilization, slit-lamp aiming, equivalent spot count) using identical laser settings, but with minimal power (50 mW, duration 10 ms) and beam offset to the adjacent non-vascular periorbital skin, ensuring no energy delivery to eyelid margin vessels, and preserving the device operational sound, laser light, and foot pedal activation. No laser energy was delivered to eyelid margin vasculature in the sham treatment, and no visible tissue reaction or blanching was observed during the procedure. The anesthesia and cleaning procedures were identical. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- chief complaint of at least one of the following symptoms: dryness, foreign-body sensation, burning, and tearing for 3 months
- diagnosis of DED secondary to MGD with eyelid margin telangiectasias in both eyes
- a baseline Ocular Surface Disease Index (OSDI) score ≥ 40
- tear break-up time (TBUT) ≤ 5 seconds
- corneal fluorescein staining ≥ 6 as per the National Eye Institute (NEI) grading scale for corneal staining.
Key exclusion criteria (6 listed)
- history of ocular trauma or surgery
- use of any treatment for DED or MGD other than artificial tears within the past 3 months
- active allergy, infection, or inflammatory disease at the ocular surface unrelated to DED or MGD
- lacrimal drainage system anomalies
- contact lens wear
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 |
|---|---|---|
| laser lightlaser photocoagulation of the telangiectatic vessels of the lower eyelid margin with a slit lamp-based 532 nm optically pumped dual- diode solid-state subthreshold (SP-Mode) laser system | Procedure or surgery | Laser Group |
| Sham treatmentSham treatment replicated all procedural steps (eyelid eversion, stabilization, slit-lamp aiming, equivalent spot count) using identical laser settings, but with minimal power (50 mW, duration 10 ms) and beam offset to the adjacent non-vascular periorbital skin, ensuring no energy delivery to eyelid margin vessels, and preserving the device operational sound, laser light, and foot pedal activation. No laser energy was delivered to eyelid margin vasculature in the sham treatment, and no visible tissue reaction or blanching was observed during the procedure. The anesthesia and cleaning procedures were identical. | Device | Control Group |
Primary outcome
Tear Break Up Time (TBUT)
Time frame: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
Using a slit-lamp biomicroscope with cobalt blue illumination, the time interval between the last complete blink and first appearance of a dark dry spot on the corneal surface was measured using a digital stopwatch. The test was repeated three times consecutively, and the mean TBUT was recorded
11 secondary outcomes
Ocular Surface Disease Index (OSDI)
Time frame: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
Lower Eyelid Tear Meniscus Height
Time frame: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
Lower Eyelid Tear Meniscus Depth
Time frame: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
Meibomography
Time frame: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
Best Corrected Visual Acuity (BCVA)
Time frame: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively
Schirmer test
Time frame: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
Eyelid margin vascularity
Time frame: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
corneal staining and the conjunctival injection
Time frame: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively
Conjunctivochalasis
Time frame: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
Meibomian gland (MG) expressibility
Time frame: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.
secretion quality
Time frame: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively
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 Jan 2026.
- Derived from this study: PubMed 41960977Kappos N, Georgalas I, Papaconstantinou D, Droutsas K. Focal Subthreshold Laser Photocoagulation of Eyelid Margin Vascularity in Telangiectatic Meibomian Gland Dysfunction. Cornea. 2026 Apr 7. doi: 10.1097/ICO.0000000000004161. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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.
Nikolaos Kappos, MD principal investigator
Naval Hospital, Athens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser light in people with Dry Eye and Dry Eye Syndromes, run by Naval Hospital, Athens at 2 sites in Greece.
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 6 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 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 2 sites in Greece. 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. Some participants in this study may receive a placebo. 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?
Tear Break Up Time (TBUT) (time frame: The subjects were evaluated at five different time points: (a) 1 day preoperatively (baseline), (b) 2 weeks (W2), (c) 4 weeks (W4), (d) 8 weeks (W8), and (e) 12 weeks (W12) postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04425551, which also lists 1 linked publication.
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 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.