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

  • STATUS
    Recruiting
  • End date
    Oct 16, 2024
  • participants needed
    264
  • sponsor
    Sun Yat-sen University
Updated on 16 May 2022
prostaglandin
corrected visual acuity
glaucoma
ophthalmic solution
brimonidine tartrate ophthalmic solution
latanoprost
intraocular pressure
brinzolamide
timolol
latanoprost 0.005% eye drops
gonioscopy
xalacom
azarga
combigan

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.

Details
Condition Glaucoma, Suspect, High Myopia
Treatment IOP lowering eye drops
Clinical Study IdentifierNCT04296916
SponsorSun Yat-sen University
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

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
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