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Effekt av IOP-sänkning på progressiv HM (PHM)

2 november 2026 uppdaterad av: Xiulan Zhang, Sun Yat-sen University

Effekt av medicinskt intraokulärt trycksänkning på progressiv hög närsynthet

Currently, whether and when intraocular pressure (IOP) lowering medication should be used in progressive high myopia (HM) to control axial elongation is still a dilemma. Randomized trials are required to evaluate whether IOP lowering influences the growth of axial length in progressive HM eyes.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Myopia has emerged as a major health issue in east Asia, especially the sight-threatening complications associated with high myopia (HM). Complication of HM can be associated with significant ocular morbidities including maculopathy, retinal detachment, and glaucoma.

Previous studies have shown that adult patients with HM have sustained growth of the axial length (AL), which is a risk factor for the progression of pathological myopia and thus may further affect the visual function , so how to slow down the sustained growth of the AL in adult patients with HM has become an urgent clinical problem. Previous studies have shown that IOP-lowering treatment is a protective factor for the growth of the AL in HM , and the results of animal experiments have further shown that medically IOP-lowering treatment can significantly slow down the AL lengthening and refractive changes in the guinea pig model of myopia. On this basis, the investigators proposed in a previous article that medically IOP-lowering treatment may slow down the growth of AL by three pathways related to the sclera and choroid: for the sclera, IOP-lowering treatment may reduce the scleral distending force, slow down the rate of scleral distension, and inhibit the activation of scleral fibroblasts to reduce scleral remodeling; for the choroid, IOP-lowering treatment may increase choroidal blood perfusion and for the choroid, hypotensive treatment can increase choroidal perfusion and thus reduce scleral remodeling due to scleral hypoxia. A previous retrospective study conducted by the investigators also shows that medically IOP-lowering treatment could control the progression of AL in HM, but there is still a lack of evidence from relevant robust randomized controlled clinical trials (RCT).

The investigators propose to conduct a RCT to evaluate whether medically IOP-lowering therapy is effective in controlling the progression of AL in HM. Secondly, this study also aims to provide data to evaluate IOP-lowering treatment effects on the incidence of changes in the visual field (VF), optic nerve head morphology including the retinal nerve fiber layer (RNFL), and retinal ganglion cell-inner plexiform layer (GC-IPL) loss, progression of myopic maculopathy, loss in visual function and change in quality of life. The outcomes of this study may provide a strong basis for treatment recommendations to control the progression of high myopic eyes, and to provide high-quality clinical research evidence for international clinical guidelines on myopia.

Studietyp

Interventionell

Inskrivning (Beräknad)

152

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
        • Zhongshan Ophthalmic Center, Sun Yat-sen University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Informed consent given, and consent form signed.
  2. Age between 18 and 65 years.
  3. Diagnosed with HM: spherical equivalent ≤ -6.00 diopters or AL ≥ 26.5 mm.
  4. Progressive HM: progression in AL ≥0.05mm in the past 6 months or ≥0.1mm in the past 12 months.
  5. IOP ≥ 10 mmHg and ≤ 21mmHg on at least 2 visits, as measured by Goldmann applanation tonometry .
  6. Best corrected visual acuity (BCVA) ≥ 6/12, and being able to obtain adequate AL examination, fundus photographs, optical coherence tomography (OCT) and complete the VF examination.

Exclusion Criteria:

  1. Allergic to any kind of IOP-lowering therapy.
  2. Combination of various serious fundus pathologies, such as proliferative diabetic retinopathy, retinal detachment, central retinal artery occlusion, etc.
  3. Combination of chronic, recurrent or severe ocular inflammatory lesions, such as chronic or recurrent uveitis.
  4. Patients with significant corneal or iris lesions, or severe cataract affecting fundus examination, or patients with only one eye.
  5. Patients who have undergone any surgery or laser treatment affecting eye parameters during the follow-up period (within the last 1 year), such as cataract surgery.
  6. Patients with other serious systemic diseases, such as hypertension, heart disease, diabetes, rheumatic immune system disease, etc., who cannot tolerate long-term follow-up and eye treatment.
  7. Pregnant or lactating women, or those who plan to have children during the follow-up period.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intervention arm

medical reduction of IOP by eyedrops
Läkemedel: Assigned Interventions: IOP-lowering eye drops

IOP-lowering eye drops Xalacom eyedrops (combination drops, fixed latanoprost with timolol) will be the choice for treatment.
Inget ingripande: control arm

follow up without medication

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Annualized change in axial length (AL) from baseline to 12 months
Tidsram: 12 months

The cumulative change in AL from baseline to 12 months.
12 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Annualized change in axial length (AL) from baseline to 24 months
Tidsram: 24 months

The cumulative change in AL from baseline to 24 months divided by 2 years.
24 months
Annualized change in axial length (AL) from baseline to 36 months
Tidsram: 36 months

The cumulative change in AL from baseline to 36 months divided by 3 years.
36 months
Change in spherical equivalent (SE) from baseline
Tidsram: 12, 24, and 36 months

Change in spherical equivalent refraction (SE) from baseline.
12, 24, and 36 months
Change in intraocular pressure (IOP) from baseline
Tidsram: 12, 24, and 36 months

Change in intraocular pressure (IOP) from baseline
12, 24, and 36 months
Change in choroidal thickness (ChT) from baseline
Tidsram: 12, 24, and 36 months

Change in subfoveal choroidal thickness (ChT) measured by OCT from baseline.
12, 24, and 36 months
Change in visual field (VF) parameters and incidence/progression of VF defects
Tidsram: 12, 24, and 36 months

Change in Humphrey 24-2 mean deviation (MD) and pattern standard deviation (PSD) from baseline, and the incidence and progression of visual field defects
12, 24, and 36 months
Change in retinal nerve fiber layer (RNFL) and ganglion cell-inner plexiform layer (GCIPL) thickness
Tidsram: 12, 24, and 36 months

Change in peripapillary RNFL and macular GCIPL thickness measured by OCT from baseline
12, 24, and 36 months
Change in retinal and choroidal vascular parameters measured by OCTA
Tidsram: 12, 24, and 36 months

Change in vessel density of the superficial capillary plexus (SCP) and deep capillary plexus (DCP), and choriocapillaris (CC) flow metrics from baseline
12, 24, and 36 months
Incidence of optic nerve head morphological changes
Tidsram: 12, 24, and 36 months

Incidence of morphological changes based on stereoscopic fundus photography, including increased cup-to-disc ratio, neuroretinal rim notching, wedge-shaped RNFL defects, or disc hemorrhage.
12, 24, and 36 months
Incidence and progression of myopic maculopathy (MMD)
Tidsram: 12, 24, and 36 months

The incidence and progression rate of myopic maculopathy classified by the international photographic classification system.
12, 24, and 36 months
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Tidsram: 1 month, 3 month, 6 month, 12 month, 24 month, 36 month

The incidence, severity, and relationship to study medication of all adverse events (AEs) and serious adverse events (SAEs)
1 month, 3 month, 6 month, 12 month, 24 month, 36 month

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sun Yat-sen University

Utredare

  • Huvudutredare: Xiulan Zhang, MD, PhD, Sun Yat-sen University

Publikationer och användbara länkar

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Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2023

Primärt slutförande (Beräknad)

20 november 2026

Avslutad studie (Beräknad)

30 november 2028

Studieregistreringsdatum

Först inskickad

13 april 2023

Först inskickad som uppfyllde QC-kriterierna

29 april 2023

Första postat (Faktisk)

9 maj 2023

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 2023KYPJ110

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