Effect of Lowering IOP in Glaucoma Suspects With HM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-17

Study Completion Date

2024-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Glaucoma, Suspect High Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open-label, single-center, randomized controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Intervention arm

medical reduction of IOP by eyedrops

Group Type EXPERIMENTAL

IOP lowering eye drops

Intervention Type DRUG

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.

control arm

follow up without medication

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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IOP lowering eye drops

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No