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| Name | Class |
|---|---|
| National and Kapodistrian University of Athens | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laser light | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Posterior margin irregularity, hyperkeratosis, lash loss, anterior blepharitis, tear debris, and tear foam | as absent (normal) or present (abnormal). | 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 |
Inclusion criteria were:
Exclusion criteria were:
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| Name | Affiliation | Role |
|---|---|---|
| Nikolaos Kappos, MD | Naval Hospital, Athens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Hospital of Athens | Athens | 11521 | Greece | |||
| First Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41960977 | Derived | 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. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| D013684 | Telangiectasis |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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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
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| Sham treatment | Device | 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. |
|
| Lower Eyelid Tear Meniscus Height | height (μm) via Anterior Segment Swept-Source Optical Coherence Tomography | 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 | 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. | 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. | 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 | 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). | 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 | 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) | 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). | 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). | 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 |
| Athens |
| Greece |
| D002318 |
| Cardiovascular Diseases |