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| Name | Class |
|---|---|
| ProSurg | UNKNOWN |
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Dry eye disease (DED) is a frequent ocular surface disease (OSD) of multifactorial origin, characterised by disruption of tear film homeostasis and associated with ocular discomfort and/or visual disturbance. Cataract surgery, which is one of the most often performed interventions worldwide, can induce or worsen the symptoms of DED. Despite lack of guidelines on DED prophylaxis before cataract surgery in the general population, there is a growing interest in this topic due to the high prevalence of postoperative DED. A recent randomised controlled trial (RCT) with one month follow-up showed that prophylactic low-level light therapy (LLLT) before and after cataract surgery in patients without pre-existing DED significantly improved postoperative tear film stability, as well as reduced ocular discomfort, compared to no prophylaxis. Apart from LLLT, another light-based treatment for DED is intense pulsed light (IPL); the treatments have shown favourable outcomes in the management of DED, both as stand-alone choices or in combination.
Dry eye disease (DED) is a frequent ocular surface disease (OSD) of multifactorial origin, characterised by disruption of tear film homeostasis and associated with ocular discomfort and/or visual disturbance. Cataract surgery, which is one of the most often performed interventions worldwide, can induce or worsen the symptoms of DED. Despite lack of guidelines on DED prophylaxis before cataract surgery in the general population, there is a growing interest in this topic due to the high prevalence of postoperative DED. A recent randomised controlled trial (RCT) with one month follow-up showed that prophylactic low-level light therapy (LLLT) before and after cataract surgery in patients without pre-existing DED significantly improved postoperative tear film stability, as well as reduced ocular discomfort, compared to no prophylaxis. Apart from LLLT, another light-based treatment for DED is intense pulsed light (IPL); the treatments have shown favourable outcomes in the management of DED, both as stand-alone choices or in combination.
There is currently no comparative data available which would allow to choose between LLLT and IPL as prophylaxis for iatrogenic DED after cataract surgery.
The primary objective of this RCT is to compare LLLT versus IPL as prophylaxis for iatrogenic DED after cataract surgery in terms of patient-reported symptoms of eye dryness at 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPL | Active Comparator | Patients in the IPL group will receive 3 sessions of IPL treatment with OptiClear device (Alma Lasers GmbH, Nuremberg, Germany) at D-7, D+7, and D+30. Each session will comprise 90 homogenously spaced pulses of light (wavelength of 550-650 nm, pulse time 10,12 or 15 ms, pulse repetition rate 1-2 Hz) using an energy density of 8-12 J/cm2 adjusted to Fitzpatrick skin type according to the manufacturer's recommendations. The treatment will be applied to the lower eyelid region. Ultrasound gel, as well as protective eye patches will be used, and the patients will be asked to close their eyes during the session. The chosen parameters are currently used in the clinical practice of the participating surgeons as treatment for DED; moreover, similar values are reported in published studies |
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| LLLT | Experimental | Patients in the LLLT group will receive 3 sessions of LLLT treatment with Eye-light device (Espansione Group S.p.A., Bologna, Italy) 7 days before phacoemulsification (D-7), 7 days after phacoemulsification (D+7), and 30 days after phacoemulsification (D+30). Each session will consist of 15 minutes of light treatment using a wavelength of 625±40 nm and maximum power of 10 W (maximal total fluence of 32 J/cm2 ± 20% per session) applied on the periorbital region. The patients will be asked to close their eyes during the session. The chosen parameters are currently used in the clinical practice of the participating surgeons as treatment for DED; moreover, similar values are reported in published studies |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LLLT | Procedure | Patients in the LLLT group will receive 3 sessions of LLLT treatment with Eye-light device (Espansione Group S.p.A., Bologna, Italy) 7 days before phacoemulsification (D-7), 7 days after phacoemulsification (D+7), and 30 days after phacoemulsification (D+30). Each session will consist of 15 minutes of light treatment using a wavelength of 625±40 nm and maximum power of 10 W (maximal total fluence of 32 J/cm2 ± 20% per session) applied on the periorbital region. The patients will be asked to close their eyes during the session. The chosen parameters are currently used in the clinical practice of the participating surgeons as treatment for DED; moreover, similar values are reported in published studies |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported symptoms of eye dryness (OSDI) | Participants will be asked to report the symptoms of eye dryness by answering an OSDI questionnaire assisted by a member of the medical staff (blinded to the randomisation). OSDI is a widely used, validated questionnaire for the diagnosis of DED and evaluation of its severity and consists of 12 items graded from 0 (never) to 4 (all the time). The final OSDI score is within the range of 0 (no disability) to 100 (complete disability) and is calculated based on the following formula: [(sum of scores for the questions answered) × 25] / (total number of questions answered). | 3 months after cataract surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported symptoms of eye dryness (OSDI) | Participants will be asked to report the symptoms of eye dryness by answering an OSDI questionnaire assisted by a member of the medical staff (blinded to the randomisation). OSDI is a widely used, validated questionnaire for the diagnosis of DED and evaluation of its severity and consists of 12 items graded from 0 (never) to 4 (all the time). The final OSDI score is within the range of 0 (no disability) to 100 (complete disability) and is calculated based on the following formula: [(sum of scores for the questions answered) × 25] / (total number of questions answered). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathieu De Bats, MD | Contact | 04 74 78 38 60 | +33 | mathieudebats@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Trenel | Sainte-Colombe | 69560 | France |
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| ID | Term |
|---|---|
| D014985 | Xerophthalmia |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| D010789 | Phototherapy |
| D062325 | Intense Pulsed Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
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A randomised controlled surgeon-blinded, evaluator-blinded monocentric trial in a non-inferiority framework with a 1:1 allocation ratio.
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Surgeons and the medical staff (the evaluators) that administer the questionnaires will be blinded to the randomisation, but the orthoptists performing the treatment will be aware of the randomisation. Participants will not be informed of their allocated treatment; however, they may guess which treatment they received as the IPL and LLLT devices look differently, and the patient can see the device being used. Moreover, the patient's experience will be different. In the IPL group, light is administered in pulses and the patients experience heat; furthermore, cooling ultrasound gel and eye patches are used for protection. In the LLLT group, light is administered continuously, and there is no protective gel nor eye patches. At the end of the study, participants may request what type of treatment they received.
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| IPL | Procedure | Patients in the IPL group will receive 3 sessions of IPL treatment with OptiClear device (Alma Lasers GmbH, Nuremberg, Germany) at D-7, D+7, and D+30. Each session will comprise 90 homogenously spaced pulses of light (wavelength of 550-650 nm, pulse time 10,12 or 15 ms, pulse repetition rate 1-2 Hz) using an energy density of 8-12 J/cm2 adjusted to Fitzpatrick skin type according to the manufacturer's recommendations. The treatment will be applied to the lower eyelid region. Ultrasound gel, as well as protective eye patches will be used, and the patients will be asked to close their eyes during the session. The chosen parameters are currently used in the clinical practice of the participating surgeons as treatment for DED; moreover, similar values are reported in published studies |
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| 1 week, 1 month after cataract surgery |
| patient-reported symptoms of eye dryness (SANDE) | Participants will answer a Symptom Assessment in Dry Eye (SANDE) questionnaire assisted by a member of the medical staff (blinded to the randomisation). SANDE consists of two questions: "How often, on average, do your eyes feel dry and/or irritated?" and "How severe, on average, do you feel your symptoms of dryness and/or irritation are?". The patient answers both of them on a 100-mm horizontal visual analogue scale (VAS). The location of the mark made by the patient for each question is measured in mm from the left-hand side of the 100-mm line. The final score is calculated by multiplying frequency and severity scores and calculating the square root of the result | 1 week after, 1 month after and 3 months after the surgery |
| Non-invasive tear film break-up time (NIBUT) | Automated corneal surface analysis using CA-900 corneal topographer (Topcon Healthcare, Tokyo, Japan) | 1 week, 1 and 3 months after cataract surgery |
| Ocular redness | Automated corneal surface analysis using CA-900 corneal topographer (Topcon Healthcare, Tokyo, Japan), on 0-4 Efron scale, grade 0 corresponding to normal ocular redness; a high quality image is obtained with CA-900 and Efron scale is displayed on the screen for a manual comparison | 1 week after, 1 and 3 months after cataract surgery |
| Meibomian gland (MG) atrophy | a) Automated corneal surface analysis using CA-900 corneal topographer (Topcon Healthcare, Tokyo, Japan), on 1-4 scale, grade 1 corresponding to <25% of MG atrophy; grade 2: 25% < atrophy < 50%; grade 3: 50% < atrophy < 75%; grade 4: atrophy > 75% | 1 week, 1 and 3 months after cataract surgery |
| Fluorescein corneal staining (FCS) | With 0.5% fluorescein (SERB SA, Bruxelles, Belgium) assessed under a slit lamp, on 1-4 scale, grade 1 corresponding to no punctate staining; grade 2: no punctate staining but eye tearing/watering; grade 3: localised punctate staining; grade 4: diffuse punctate staining or staining fused in plaques | 1 week, 1 and 3 months after cataract surgery |
| Eyelid telangiectasias | Assessed under a slit lamp, on 1-4 scale, grade 1 corresponding to no telangiectasias; grade 2: eyelid (skin) or eyelid margin telangiectasias; grade 3: superficial telangiectasias of inferior palpebral conjunctiva; grade 4: deep telangiectasias of inferior palpebral conjunctiva | 1 week after, 1 and 3 months after cataract surgery |
| Meibomian expressiblity and quality | Assessed under a slit lamp, on 1-4 scale, grade 1 corresponding to no MG obstruction, clear and easily expressed meibum; grade 2: cloudy meibum of abnormal viscosity; grade 3: thick, toothpaste-like or filament-like meibum, difficult to express; grade 4: MG obstruction with no meibum expression even under significant pressure | 1 week, 1 and 3 months after cataract surgery, |
| Ultrasound energy delivered | Collected during the cataract surgery as cumulative dissipated energy (CDE), obtained as an automatically calculated value displayed at the end of the surgery on the screen of the phacoemulsification system | Intra-operatively |
| Adverse Events | Including complications and reoperations, specifying the incidence, severity, and relationship to the treatment applied | 0 to 3 months after cataract surgery |