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Effect of Lowering IOP in Glaucoma Suspects With HM (GSHM)

Primary Purpose

Glaucoma, Suspect, High Myopia

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

IOP lowering eye drops

About this trial

This is an interventional prevention trial for Glaucoma, Suspect focused on measuring Glaucoma, Suspect, High myopia, Intraocular Pressure

Eligibility Criteria

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

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

Zhongshan Ophthalmic CenterRecruiting

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

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT04296916

First Posted

March 3, 2020

Last Updated

May 4, 2022

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT04296916

Brief Title

Effect of Lowering IOP in Glaucoma Suspects With HM

Acronym

GSHM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 17, 2020 (Actual)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

October 2024 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Suspect, High Myopia

Keywords

Glaucoma, Suspect, High myopia, Intraocular Pressure

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

264 (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)

IOP lowering eye drops

Intervention Description

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. If necessary, latanoprost will be switched to other prostaglandin eye drops, alphagan (or alphagan-P) will be switched to brinzolamide 1% eye drops. 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. Once daily in the evening for prostaglandin eye drops, and twice daily for other eye drops.

Primary Outcome Measure Information:

Title

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

Time Frame

36 months

Secondary Outcome Measure Information:

Title

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

Time Frame

36 months

Title

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

Time Frame

36 months

Title

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

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiulan Zhang, MD, PhD

Phone

+86 13570166308

zhangxl2@mail.sysu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Fengbin Lin

Phone

+86 13826067110

linfb52@163.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

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

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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

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

result

PubMed Identifier

32993769

Citation

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.

Results Reference

derived

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Effect of Lowering IOP in Glaucoma Suspects With HM

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