High MyopiaPHMNCT05850936
Effect of IOP Lowering on Progressive HM
A study testing Assigned Interventions: IOP-lowering eye drops in people with High Myopia and Intraocular Pressure, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- High Myopia, Intraocular Pressure
- What is being tested?
- Assigned Interventions: IOP-lowering eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Effect of Medically Intraocular Pressure Lowering on Progressive High Myopia
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.
Read the 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.
- Conditions
- High Myopia, Intraocular Pressure
- Being tested
- Assigned Interventions: IOP-lowering eye drops
- Keywords
- high myopia, intraocular pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned Interventions: IOP-lowering eye dropsDrug
IOP-lowering eye drops Xalacom eyedrops (combination drops, fixed latanoprost with timolol) will be the choice for treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | medical reduction of IOP by eyedrops Receives: Drug: Assigned Interventions: IOP-lowering eye drops |
| control arm | No intervention | follow up without medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression of axial length (AL)
The number of subjects whose AL progressed during the follow up
Measured: 12 months
Secondary outcomes (3)
Incidence of visual field (VF) defects or progression
The number of subjects whose VF defects progressed during the follow up
Measured: 12 months
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
Measured: 12 months
progression of myopic maculopathy
The number of subjects whose myopic maculopathy progressed during the follow up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Jun 2023
- Primary completion20 Nov 2026 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for High MyopiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, single-center, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiulan Zhang, Sun Yat-sen University
- Investigators
- Xiulan Zhang, MD, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850936
- Sponsor's protocol ID
- 2023KYPJ110
- Acronym
- PHM
- Status last verified
- May 2026
- First submitted
- 13 Apr 2023
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10334369Garway-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.
PubMed 25533656Leske 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.
PubMed 10571351Jiang J, Lin T, Lin F, Kong K, Wang P, Song Y, Zhou F, Wang Z, Jin L, Liu Y, Gao X, Chen J, Chen M, Lam DSC, Jonas JB, Chen S, Zhang X; Glaucoma Suspects with High Myopia Study Group. Effect of intraocular pressure reduction on progressive high myopia (PHM study): study protocol of a randomised controlled trial. BMJ Open. 2024 Jun 5;14(6):e084068. doi: 10.1136/bmjopen-2024-084068.
PubMed 38839388
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Medically Intraocular Pressure Lowering on Progressive High Myopia
- ClinicalTrials.gov ID
- NCT05850936
- Acronym / sponsor ID
- PHM / 2023KYPJ110
- Conditions
- High Myopia, Intraocular Pressure
- Keywords
- high myopia, intraocular pressure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Open-label, single-center, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Drug: Assigned Interventions: IOP-lowering eye dropsmedical reduction of IOP by eyedrops |
| control arm | No intervention | –follow up without medication |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 .
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assigned Interventions: IOP-lowering eye dropsIOP-lowering eye drops Xalacom eyedrops (combination drops, fixed latanoprost with timolol) will be the choice for treatment. | Drug | Intervention arm |
Primary outcome
progression of axial length (AL)
Time frame: 12 months
The number of subjects whose AL progressed during the follow up
3 secondary outcomes
Incidence of visual field (VF) defects or progression
Time frame: 12 months
Incidence of changes in the optic nerve head morphology including the retinal nerve fiber layer (RNFL) and ganglion cell-inner plexiform layer (GCIPL)
Time frame: 12 months
progression of myopic maculopathy
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Background: PubMed 10334369Leske 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.
- Background: PubMed 25533656Garway-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.
- Background: PubMed 10571351Leske 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.
- Derived from this study: PubMed 38839388Jiang J, Lin T, Lin F, Kong K, Wang P, Song Y, Zhou F, Wang Z, Jin L, Liu Y, Gao X, Chen J, Chen M, Lam DSC, Jonas JB, Chen S, Zhang X; Glaucoma Suspects with High Myopia Study Group. Effect of intraocular pressure reduction on progressive high myopia (PHM study): study protocol of a randomised controlled trial. BMJ Open. 2024 Jun 5;14(6):e084068. doi: 10.1136/bmjopen-2024-084068.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiulan Zhang, MD, PhD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned Interventions: IOP-lowering eye drops in people with High Myopia and Intraocular Pressure, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression of axial length (AL) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05850936, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.