Clinical trial NCT04296916: Effect of Lowering IOP in Glaucoma Suspects With HM
Official title: Effect of Medically Lowering Intraocular Pressure in Glaucoma Suspects With High Myopia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma, Suspect
High Myopia
Keywords: Glaucoma, Suspect
High myopia
Intraocular Pressure
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 264
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, single-center, randomized controlled trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The number of subjects whose visual filed progressed during the follow up
timeFrame: 36 months
Secondary outcomes:
measure: 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
timeFrame: 36 months
measure: The number of subjects whose myopic maculopathy progressed during the follow up
timeFrame: 36 months
measure: The number of subjects whose visual function and quality of life changed during follow up
timeFrame: 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Xiulan Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.