Effect of Lowering IOP in Glaucoma Suspects With HM

High Myopia Clinical Trial

— GSHM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04296916
• Other study ID #: 2020KYPJ026
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2020
• Est. completion date: October 2024

Study information

• Verified date: May 2022
• Source: Sun Yat-sen University
• Contact: Xiulan Zhang, MD, PhD
• Phone: +86 13570166308
• Email: zhangxl2[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Aged between 35 and 65 years.

2. Diagnosed with high myopia (spherical equivalent = -8.00 diopters or axial length = 26.5 mm).

3. Diagnosed with glaucoma suspect, which cannot be explained by myopic macular changes, or other retinal and neurologic condition.

4. IOP = 12 mmHg and = 24mmHg on at least 2 visits, as measured by Goldmann applanation tonometry.

5. An open anterior chamber angle as based upon gonioscopy.

6. Best corrected visual acuity (BCVA) = 6/12.

Exclusion Criteria:

1. Allergy to prostaglandins.

2. 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.

3. Previous IOP-lowering surgery in the study eye (i.e. trabeculectomy, Ahmed glaucoma valve implantation, any laser trabeculoplasty).

4. Previous cataract surgery in the study eye.

5. Previous corneal refractive surgery in the study eye.

6. Clinically significant or progressive retinal disease such as proliferative diabetic retinopathy, retinal detachment, central retinal vein occlusion, or retinitis pigmentosa in the study eye.

7. Chronic, recurrent or severe inflammatory eye disease in the study eye (from screening), such as chronic or recurrent uveitis.

8. Obvious corneal and iris lesions, or severe cataracts interfering with fundus examinations, or monophtalmia.

9. 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.

10. Other serious systemic diseases (i.e. hypertension, heart disease, diabetes, or rheumatic immune system diseases).

11. Pregnant or nursing women.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Suspect
• High Myopia
• Myopia
• Ocular Hypertension

Intervention

Drug:
• IOP lowering eye drops
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.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

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 — View Citation

Leske MC, Heijl A, Hyman L, Bengtsson B. Early Manifest Glaucoma Trial: design and baseline data. Ophthalmology. 1999 Nov;106(11):2144-53. — View 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 r — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of subjects whose visual filed progressed during the follow up		36 months
Secondary	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		36 months
Secondary	The number of subjects whose myopic maculopathy progressed during the follow up		36 months
Secondary	The number of subjects whose visual function and quality of life changed during follow up		36 months