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Glaucoma, SuspectGSHMNCT04296916

Effect of Lowering IOP in Glaucoma Suspects With HM

A study testing IOP lowering eye drops in people with Glaucoma, Suspect and High Myopia, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Currently, whether and when intraocular pressure (IOP) lowering medication should be used in glaucoma suspects with high myopia (HM) is still a dilemma. Randomized trials are required to evaluate whether IOP lowering influences the incidence of glaucoma suspect progression in HM eyes. Read more about this study

Who is it for?
Ages 35 to 65 years
Conditions the study is for
Glaucoma, Suspect, High Myopia
What is being tested?
IOP lowering eye drops
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
1 siteChina
Study dates
17 Apr 2020to Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

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 35 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged between 35 and 65 years.
  • Diagnosed with high myopia (spherical equivalent ≤ -8.00 diopters or axial length ≥ 26.5 mm).
  • Diagnosed with glaucoma suspect, which cannot be explained by myopic macular changes, or other retinal and neurologic condition.
  • IOP ≥ 12 mmHg and ≤ 24mmHg on at least 2 visits, as measured by Goldmann applanation tonometry.
  • An open anterior chamber angle as based upon gonioscopy.
  • Best corrected visual acuity (BCVA) ≥ 6/12.

Who cannot join

  • Allergy to prostaglandins.
  • Advanced VF loss (MD worse than 16 dB) or a threat to fixation (sensitivity 10 dB or worse affecting either or both test points closest to the point of fixation in the upper hemifield and at either or both of the corresponding test points in the lower hemifield) in either eye.
  • Previous IOP-lowering surgery in the study eye (i.e. trabeculectomy, Ahmed glaucoma valve implantation, any laser trabeculoplasty).
  • Previous cataract surgery in the study eye.
  • Previous corneal refractive surgery in the study eye.
  • Clinically significant or progressive retinal disease such as proliferative diabetic retinopathy, retinal detachment, central retinal vein occlusion, or retinitis pigmentosa in the study eye.
Show all 11Show fewer
  • Chronic, recurrent or severe inflammatory eye disease in the study eye (from screening), such as chronic or recurrent uveitis.
  • Obvious corneal and iris lesions, or severe cataracts interfering with fundus examinations, or monophtalmia.
  • Need for ocular surgery/laser or anticipated need for cataract surgery that would influence the ophthalmological parameters measured in this study during the study period.
  • Other serious systemic diseases (i.e. hypertension, heart disease, diabetes, or rheumatic immune system diseases).
  • Pregnant or nursing women.

Trial locations and contacts

1 site in 1 country.

Xiulan Zhang, MD, PhD contact

+86 13570166308

zhangxl2@mail.sysu.edu.cn

Fengbin Lin contact

+86 13826067110

linfb52@163.com

China1 site, 1 recruiting

  • Zhongshan Ophthalmic Center

    Guangzhou, Guangdong, 510060

    Xiulan Zhang, MD, PHD

    Recruiting

Other trials in China

About this study

Official title: Effect of Medically Lowering Intraocular Pressure in Glaucoma Suspects With High Myopia: A Randomized Controlled Trial

Currently, whether and when intraocular pressure (IOP) lowering medication should be used in glaucoma suspects with high myopia (HM) is still a dilemma. Randomized trials are required to evaluate whether IOP lowering influences the incidence of glaucoma suspect progression in HM eyes.

Read the detailed description

HM is associated with increased prevalence of glaucoma. However, accurate diagnosis of glaucoma in HM is a challenge. More and more viewpoints had been raised that HM eyes with optic disc head damage or/and visual field (VF) defects should been classified as glaucoma suspects.

IOP is the only modifiable parameter in glaucoma and glaucoma suspect patients. However, the decision to begin treatment to lower IOP in the glaucoma suspect patient is complex, especially for glaucoma suspects with HM. There are lack of guideline and consensus of treatment choices. Therefore, it is necessary to investigate the effect of medically IOP lowering on the progression of glaucoma suspects with HM.

Being tested
IOP lowering eye drops
Keywords
Glaucoma, Suspect, High myopia, Intraocular Pressure
Medical subject headings
Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IOP lowering eye dropsDrug

    1. Latanoprost 0.005% eye drops will be the first choice. If an IOP reduction of 20% is not achieved within three months, timolol 0.5% will be added as second medication. If an IOP reduction of 20% is then not achieved, alphagan 0.2% or alphagan-P 0.15% will be added. If an IOP reduction of 20% is then not achieved, the individual will be excluded from the study.
    2. If necessary, latanoprost will be switched to other prostaglandin eye drops, alphagan (or alphagan-P) will be switched to brinzolamide 1% eye drops.
    3. If necessary, latanoprost and timolol will be switched to Xalacom eye drops, timolol and alphagan will be switched to Combigan eye drops, timolol and brinzolamide will be switched to Azarga eye drops.
    4. Once daily in the evening for prostaglandin eye drops, and twice daily for other eye drops.
Study groups in NCT04296916
Study groupRoleWhat they receive
Intervention armExperimentalmedical reduction of IOP by eyedrops
Receives: Drug: IOP lowering eye drops
control armNo interventionfollow up without medication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of subjects whose visual filed progressed during the follow up

    Measured: 36 months

Secondary outcomes (3)

  1. The number of subjects whose optic nerve head morphology including the retinal nerve fiber layer (RNFL) and ganglion cell-inner plexiform layer (GCIPL) changed during the follow up

    Measured: 36 months

  2. The number of subjects whose myopic maculopathy progressed during the follow up

    Measured: 36 months

  3. The number of subjects whose visual function and quality of life changed during follow up

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2020
  2. Study start17 Apr 2020
  3. Primary completionOct 2024 (estimated)
  4. Study completionOct 2024 (estimated)

Resources

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
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04296916
Sponsor's protocol ID
2020KYPJ026
Acronym
GSHM
Status last verified
May 2022
First submitted
3 Mar 2020
Last updated
6 May 2022
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 10334369

  • 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.

    PubMed 25533656

  • 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.

    PubMed 10571351

  • Lin FB, Da Chen S, Song YH, Wang W, Jin L, Liu BQ, Liu YH, Chen ML, Gao K, Friedman DS, Jonas JB, Aung T, Lv L, Liu YZ, Zhang XL; GSHM study group. Effect of medically lowering intraocular pressure in glaucoma suspects with high myopia (GSHM study): study protocol for a randomized controlled trial. Trials. 2020 Sep 29;21(1):813. doi: 10.1186/s13063-020-04748-7.

    PubMed 32993769

Questions about this trial

What is this clinical trial studying?

A study testing IOP lowering eye drops in people with Glaucoma, Suspect and High Myopia, 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 11 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: status not confirmed, as of the sponsor's last update on 6 May 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiulan Zhang, MD, PhD (+86 13570166308, zhangxl2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of subjects whose visual filed progressed during the follow up (time frame: 36 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 NCT04296916, 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 6 May 2022.

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