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Effect of IOP Lowering on Progressive HM

Primary Purpose

High Myopia, Glaucoma, Suspect

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Assigned Interventions: IOP-lowering eye drops
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for High Myopia focused on measuring high myopia, glaucoma suspect

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Informed consent given, and consent form signed. Age between 18 and 65 years. Diagnosed with HM: spherical equivalent ≤ -6.00 diopters or AL ≥ 26.5 mm. Progressive HM: progression in AL ≥0.05mm in the past 6 months or ≥0.1mm in the past 12 months. IOP ≥ 10 mmHg and ≤ 21mmHg on at least 2 visits, as measured by Goldmann applanation tonometry . 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: Allergic to any kind of IOP-lowering therapy. Combination of various serious fundus pathologies, such as proliferative diabetic retinopathy, retinal detachment, central retinal artery occlusion, etc. Combination of chronic, recurrent or severe ocular inflammatory lesions, such as chronic or recurrent uveitis. Patients with significant corneal or iris lesions, or severe cataract affecting fundus examination, or patients with only one eye. 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. 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. Pregnant or lactating women, or those who plan to have children during the follow-up period.

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

control arm

Arm Description

medical reduction of IOP by eyedrops

follow up without medication

Outcomes

Primary Outcome Measures

progression of axial length (AL)
The number of subjects whose AL progressed during the follow up

Secondary Outcome Measures

Incidence of visual field (VF) defects or progression
The number of subjects whose VF defects progressed during the follow up
Incidence of changes in the optic nerve head morphology including the retinal nerve fiber layer (RNFL) and ganglion cell-inner plexiform layer (GCIPL)
The number of subjects whose optic nerve head morphology including the RNFL and GCIPL changed during the follow up
progression of myopic maculopathy
The number of subjects whose myopic maculopathy progressed during the follow up
change of quality of life (EQ-5D-5L)
The number of subjects whose EQ-5D-5L changed during follow up

Full Information

First Posted
April 13, 2023
Last Updated
September 14, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05850936
Brief Title
Effect of IOP Lowering on Progressive HM
Official Title
Effect of Medically Intraocular Pressure Lowering on Progressive High Myopia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Myopia, Glaucoma, Suspect
Keywords
high myopia, glaucoma suspect

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open-label, single-center, randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Participants and physicians are not masked as to the treatment assignment. The study outcomes will be obtained by masked ophthalmic technicians according to standard protocols and read by masked graders at the End Point Adjudication Committee. The masking status of the technicians collecting data will be recorded at each study visit. The study data will be analyzed by masked researchers.
Allocation
Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
medical reduction of IOP by eyedrops
Arm Title
control arm
Arm Type
No Intervention
Arm Description
follow up without medication
Intervention Type
Drug
Intervention Name(s)
Assigned Interventions: IOP-lowering eye drops
Intervention Description
IOP-lowering eye drops Xalacom eyedrops (combination drops, fixed latanoprost with timolol) will be the first choice for treatment. If the IOP reduction of 10% is then not achieved at 1 month, Brinzolamide 1% will be added; If the IOP reduction of 10% is then not achieved at 1 month after adding Brinzolamide 1%, Alphagan 0.2% or Alphagan-P 0.15% eye drops will be added. If an individual is allergic to Xalacom or feels uncomfortable, the eye drops will be switched to Azarga eye drops (combination drops, fixed Brinzolamide with Timolol); If the IOP reduction of 10% is then not achieved at 1 month, Brinzolamide 1% will be added. The effect of IOP lowering would be assessed every week after applying each medication until the target IOP was achieved and follow up the schedule time. If an IOP reduction of 10% is then not achieved, the individual will be excluded from the study.
Primary Outcome Measure Information:
Title
progression of axial length (AL)
Description
The number of subjects whose AL progressed during the follow up
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence of visual field (VF) defects or progression
Description
The number of subjects whose VF defects progressed during the follow up
Time Frame
12 months
Title
Incidence of changes in the optic nerve head morphology including the retinal nerve fiber layer (RNFL) and ganglion cell-inner plexiform layer (GCIPL)
Description
The number of subjects whose optic nerve head morphology including the RNFL and GCIPL changed during the follow up
Time Frame
12 months
Title
progression of myopic maculopathy
Description
The number of subjects whose myopic maculopathy progressed during the follow up
Time Frame
12 months
Title
change of quality of life (EQ-5D-5L)
Description
The number of subjects whose EQ-5D-5L changed during follow up
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent given, and consent form signed. Age between 18 and 65 years. Diagnosed with HM: spherical equivalent ≤ -6.00 diopters or AL ≥ 26.5 mm. Progressive HM: progression in AL ≥0.05mm in the past 6 months or ≥0.1mm in the past 12 months. IOP ≥ 10 mmHg and ≤ 21mmHg on at least 2 visits, as measured by Goldmann applanation tonometry . 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: Allergic to any kind of IOP-lowering therapy. Combination of various serious fundus pathologies, such as proliferative diabetic retinopathy, retinal detachment, central retinal artery occlusion, etc. Combination of chronic, recurrent or severe ocular inflammatory lesions, such as chronic or recurrent uveitis. Patients with significant corneal or iris lesions, or severe cataract affecting fundus examination, or patients with only one eye. 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. 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. Pregnant or lactating women, or those who plan to have children during the follow-up period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiulan Zhang, MD, PhD
Phone
+86 13570166308
Email
zhangxl2@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jingwen Jiang, MD
Phone
+86 15623512305
Email
568314041@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiulan Zhang, MD, PhD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiulan Zhang, MD, PhD
Phone
+86 13059106657
Email
zhangxl2@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Xinbo Gao, MD, PhD
Phone
+86 18319579657
Email
gaoxb@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10571351
Citation
Leske MC, Heijl A, Hyman L, Bengtsson B. Early Manifest Glaucoma Trial: design and baseline data. Ophthalmology. 1999 Nov;106(11):2144-53. doi: 10.1016/s0161-6420(99)90497-9.
Results Reference
background
PubMed Identifier
10334369
Citation
Leske MC, Hyman L, Hussein M, Heijl A, Bengtsson B. Comparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressures. The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Am J Ophthalmol. 1999 May;127(5):625-6. No abstract available.
Results Reference
result
PubMed Identifier
25533656
Citation
Garway-Heath DF, Crabb DP, Bunce C, Lascaratos G, Amalfitano F, Anand N, Azuara-Blanco A, Bourne RR, Broadway DC, Cunliffe IA, Diamond JP, Fraser SG, Ho TA, Martin KR, McNaught AI, Negi A, Patel K, Russell RA, Shah A, Spry PG, Suzuki K, White ET, Wormald RP, Xing W, Zeyen TG. Latanoprost for open-angle glaucoma (UKGTS): a randomised, multicentre, placebo-controlled trial. Lancet. 2015 Apr 4;385(9975):1295-304. doi: 10.1016/S0140-6736(14)62111-5. Epub 2014 Dec 19. Erratum In: Lancet. 2015 Jul 11;386(9989):136.
Results Reference
result

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Effect of IOP Lowering on Progressive HM

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