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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | medical reduction of IOP by eyedrops |
|
| control arm | No Intervention | follow up without medication |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IOP lowering eye drops | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects whose visual filed progressed during the follow up | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| The number of subjects whose myopic maculopathy progressed during the follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiulan Zhang, MD, PhD | Contact | +86 13570166308 | zhangxl2@mail.sysu.edu.cn | |
| Fengbin Lin | Contact | +86 13826067110 | linfb52@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiulan Zhang, MD, PhD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10334369 | Result | 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. | |
| 25533656 |
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| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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Open-label, single-center, randomized controlled trial
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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.
|
| 36 months |
| The number of subjects whose visual function and quality of life changed during follow up | 36 months |
| 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. |
| 10571351 | Result | 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. |
| 32993769 | Derived | 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. |