An interventional study of laser light and Sham treatment in Dry Eye, Dry Eye Syndromes and Meibomian Gland Dysfunction, sponsored by Naval Hospital, Athens. Completed at 2 sites in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Naval Hospital, Athens · Not applicable, Interventional, and Treatment
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.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
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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.
Procedure: laser light
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.
Device: Sham treatment
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 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.
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
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.
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.
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
height (μm) via Anterior Segment Swept-Source Optical Coherence Tomography
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
depth (μm) via Anterior Segment Swept-Source Optical Coherence Tomography
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
scale (0,1,2,3). Higher values represent greater disability.
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)
using Snellen charts, which was converted to logMAR values for statistical analysis purposes.
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
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
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
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).
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
using fluorescein dye, according to the National Eye Institute (NEI) scale
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
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)
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
by applying standardized digital pressure to the central third of the lower lid, graded as 1 (light), 2 (moderate), or 3 (heavy pressure required).
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
0 (clear), 1 (cloudy), 2 (granular), or 3 (toothpaste-like).
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
Posterior margin irregularity, hyperkeratosis, lash loss, anterior blepharitis, tear debris, and tear foam
as absent (normal) or present (abnormal).
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
Plan to share: No
Ran from Dec 2022 to primary completion in Apr 2025, 27 months.
Of 199 non-industry interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's 27 months is above that.
Counting every sponsor, half of 312 studies reached it within 10 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Naval Hospital, Athens