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- Registre américain des essais cliniques
- Essai clinique NCT07748546
The Rebound Effect on Repeated Low-Level Red Light Therapy for Myopia
The Rebound Effect on Repeated Low-Level Red Light Therapy for Myopia: A Randomized Controlled Clinical Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Myopia is a public health issue of global concern, with its incidence and severity increasing annually, particularly among children and adolescents. Projections indicate that by 2050, the global prevalence of myopia will reach as high as 49.8%, with the prevalence of high myopia reaching 9.8% .With the rising prevalence of myopia, the risk of myopia-related complications has increased significantly, including cataracts, glaucoma, myopic macular degeneration, and retinal detachment. Without proper management, these conditions can lead to severe visual impairment and substantial societal burdens. Therefore, preventing and slowing the onset and progression of myopia has become a critical strategy in myopia control efforts.
Repeated low-level red light (RLRL) therapy is an emerging treatment modality for myopia control. In a 12-month multicenter randomized clinical trial, the RLRL group demonstrated a 69.4% reduction in axial length elongation and a 76.6% decrease in myopic refractive progression compared to the single-vision spectacle (SVS) group. Furthermore, RLRL therapy showed superior efficacy in patients with high myopia, achieving an axial length reduction of over 0.05 mm in 53.3%-59% of cases.Comparative studies on the efficacy of atropine in controlling myopia demonstrated that, after 12 months of use, the RLRL therapy significantly outperformed 0.01% atropine in controlling axial length.In myopic patients who still exhibit poor control of axial length despite wearing orthokeratology lenses, combined use of RLRL therapy significantly inhibits axial growth.
Given that myopia typically progresses continuously during childhood, Xiong et al. investigated the long-term efficacy and safety of RLRL therapy over a period exceeding two years. The results demonstrated good tolerability of RLRL therapy, with an efficacy rate of 75% in terms of axial length reduction and myopic refractive control after two years of treatment; however, the therapeutic efficacy declined in the second year compared to the first year.Additionally, similar to other myopia intervention strategies, a rebound effect was observed in patients who discontinued RLRL treatment after one year; in these patients, their myopia progression rate during the second year was comparable to the progression level observed in the SVS group during its first year.
To further investigate the long-term efficacy of RLRL treatment and rebound effects after treatment discontinuation, as well as to explore strategies for mitigating these rebound effects, this study focused on participants who received continuous RLRL therapy for one year. It examined the rebound effects in axial length (AL) and spherical equivalent refractive power (SER) among participants who discontinued or gradually reduced RLRL treatment compared to those who continued treatment.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Lixia Feng, Doctor
- Numéro de téléphone: +8613075590585
- E-mail: lixiafeng75@fy.ahmu.edu.cn
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- 8 to 16 years old
- Rceived continuous RLRL treatment for 1 year (±1 month) without interruption.
- Diagnosed with myopia (ciliary muscle paralysis SER ≥ -0.50 D), astigmatism ≤ 2.50 D, anisometropia ≤ 1.50 D, and bilateral best corrected visual acuity (BCVA) ≥ Snellen 20/20 before receiving RLRL treatment.
- The consent of the guardian and the consent of the participant.
Exclusion Criteria:
- History of any ophthalmic surgery or ocular diseases (e.g., glaucoma, retinal disorders).
- Systemic diseases that affect vision or eye health (e.g., diabetes). After discontinuing RLRL treatment, other myopia control interventions other than monocular glasses should be employed (including atropine, orthokeratology lenses, defocused/DOT lenses, etc.).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: the continued RLRL treatment group(RLRL-C)
The pediatric participants had received continuous Repeated low-level red light(RLRL) treatment for one year and continue to receive RLRL treatment for one more year.
|
Repeated low-level red light (RLRL) therapy is an emerging treatment modality for myopia control.
The participants were randomly assigned to three groups: the continued RLRL treatment group (RLRL-C), the discontinued RLRL treatment group (RLRL-I), and the gradually reduced RLRL treatment group (RLRL-T).
|
|
Expérimental: the discontinued RLRL treatment group (RLRL-I)
The pediatric participants had received continuous Repeated low-level red light(RLRL) treatment for one year and discontinue RLRL treatment for one year.
|
Repeated low-level red light (RLRL) therapy is an emerging treatment modality for myopia control.
The participants were randomly assigned to three groups: the continued RLRL treatment group (RLRL-C), the discontinued RLRL treatment group (RLRL-I), and the gradually reduced RLRL treatment group (RLRL-T).
|
|
Expérimental: the gradually reduced RLRL treatment group (RLRL-T)
The pediatric participants had received continuous Repeated low-level red light(RLRL) treatment for one year and gradually reduce the RLRL treatment for one year(First month: twice daily, for 5 days per week;Second month: Once daily, for 5 days per week;Third month: once daily, for 3 days per week).
|
Repeated low-level red light (RLRL) therapy is an emerging treatment modality for myopia control.
The participants were randomly assigned to three groups: the continued RLRL treatment group (RLRL-C), the discontinued RLRL treatment group (RLRL-I), and the gradually reduced RLRL treatment group (RLRL-T).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Axial length(AL)
Délai: Baseline, 6 months and12 months.
|
Change from baseline in Axial length [Unit of Measure:mm]
|
Baseline, 6 months and12 months.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Spherical Equivalent Refraction (SER)
Délai: Baseline, 6 Months, 12 Months
|
Mean change from baseline in spherical equivalent refraction [ Unit of Measure: Diopters (D) ]
|
Baseline, 6 Months, 12 Months
|
|
Best-Corrected Visual Acuity (BCVA)
Délai: Baseline, 6 Months, 12 Months
|
Change from baseline in best-corrected visual acuity measured using the ETDRS chart [Unit of Measure: LogMAR]
|
Baseline, 6 Months, 12 Months
|
|
corneal curvature
Délai: Baseline, 6 Months, 12 Months
|
Change from baseline in mean corneal curvature (K-readings) [Unit of Measure: Diopters]
|
Baseline, 6 Months, 12 Months
|
|
Anterior Chamber Depth (ACD)
Délai: Baseline,6 months and 12 months.
|
Change from baseline in anterior chamber depth (Unit of Measure:mm)
|
Baseline,6 months and 12 months.
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KY2026-03-88
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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