Effect of IOP Lowering on Progressive HM

NCT05850936 | Active Not Recruiting DMC

• 1 other identifier: 2023KYPJ110
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, whether and when intraocular pressure (IOP) lowering medication should be used in progressive high myopia (HM) to control axial elongation is still a dilemma. Randomized trials are required to evaluate whether IOP lowering influences the growth of axial length in progressive HM eyes.

Conditions

High Myopia; Intraocular Pressure

Keywords

high myopia; intraocular pressure

Outcome Measures

Primary Outcomes (1)

• progression of axial length (AL)

  The number of subjects whose AL progressed during the follow up

  12 months

Secondary Outcomes (3)

• Incidence of visual field (VF) defects or progression

  12 months

• Incidence of changes in the optic nerve head morphology including the retinal nerve fiber layer (RNFL) and ganglion cell-inner plexiform layer (GCIPL)

  12 months

• progression of myopic maculopathy

  12 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

medical reduction of IOP by eyedrops

Drug: Assigned Interventions: IOP-lowering eye drops

control arm

NO INTERVENTION

follow up without medication

Interventions

Assigned Interventions: IOP-lowering eye drops DRUG

IOP-lowering eye drops Xalacom eyedrops (combination drops, fixed latanoprost with timolol) will be the choice for treatment.

Intervention arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent given, and consent form signed.
• Age between 18 and 65 years.
• Diagnosed with HM: spherical equivalent ≤ -6.00 diopters or AL ≥ 26.5 mm.
• Progressive HM: progression in AL ≥0.05mm in the past 6 months or ≥0.1mm in the past 12 months.
• IOP ≥ 10 mmHg and ≤ 21mmHg on at least 2 visits, as measured by Goldmann applanation tonometry .
• Best corrected visual acuity (BCVA) ≥ 6/12, and being able to obtain adequate AL examination, fundus photographs, optical coherence tomography (OCT) and complete the VF examination.

You may not qualify if:

• Allergic to any kind of IOP-lowering therapy.
• Combination of various serious fundus pathologies, such as proliferative diabetic retinopathy, retinal detachment, central retinal artery occlusion, etc.
• Combination of chronic, recurrent or severe ocular inflammatory lesions, such as chronic or recurrent uveitis.
• Patients with significant corneal or iris lesions, or severe cataract affecting fundus examination, or patients with only one eye.
• Patients who have undergone any surgery or laser treatment affecting eye parameters during the follow-up period (within the last 1 year), such as cataract surgery.
• Patients with other serious systemic diseases, such as hypertension, heart disease, diabetes, rheumatic immune system disease, etc., who cannot tolerate long-term follow-up and eye treatment.
• Pregnant or lactating women, or those who plan to have children during the follow-up period.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (4)

• 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.

  PMID: 10334369 BACKGROUND

• 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.

  PMID: 25533656 BACKGROUND

• 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.

  PMID: 10571351 BACKGROUND

• Jiang J, Lin T, Lin F, Kong K, Wang P, Song Y, Zhou F, Wang Z, Jin L, Liu Y, Gao X, Chen J, Chen M, Lam DSC, Jonas JB, Chen S, Zhang X; Glaucoma Suspects with High Myopia Study Group. Effect of intraocular pressure reduction on progressive high myopia (PHM study): study protocol of a randomised controlled trial. BMJ Open. 2024 Jun 5;14(6):e084068. doi: 10.1136/bmjopen-2024-084068.

  PMID: 38839388 DERIVED

Related Links

• Related Info

Study Officials

• Xiulan Zhang, MD, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research Center

Model Details: Open-label, single-center, randomized controlled trial

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 9, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 30, 2028
• Last Updated: March 16, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)