A randomized control trial evaluating the efficacy of additional intraocular pressure lowering treatment upon detection of lamina cribrosa deformation

• Register: ChiCTR
• Last refreshed on: 30 April 2018
• Main ID: ChiCTR-IOR-14005592
• Date of registration: 2014-11-24
• Prospective Registration: Yes
• Primary sponsor: Hong Kong Eye Hospital, The Chinese University of Hong Kong
• Public title: A randomized control trial evaluating the efficacy of additional intraocular pressure lowering treatment upon detection of lamina cribrosa deformation
• Scientific title: A randomized control trial evaluating the efficacy of additional intraocular pressure lowering treatment upon detection of lamina cribrosa deformation
• Date of first enrolment: 2014-12-05
• Target sample size: Intervention vs control:485;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=9984
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Other

Countries of recruitment

China

Contacts

• Name: Ms. Jennifer Tsoi
• Affiliation: Hong Kong Eye Hospital, The Chinese University of Hong Kong

• Name: Prof. Leung Christopher Kai Shun
• Affiliation: Hong Kong Eye Hospital, The Chinese University of Hong Kong

Key inclusion & exclusion criteria

Inclusion criteria: 1. To be aged older than 18 years;
2. Best corrected visual acuity more than 20/40;
3. POAG patients diagnosed within 12 months without prior history of glaucoma surgical/laser procedure and receiving not more than one topical IOP lowering medication.
Exclusion criteria: IOP higher than 30mmHg measured at any time points during the screening visit; high myopia (spherical error less than -6.0D); moderate and advanced VF loss (VF MD less than -6dB in the worse eye) or defects close to fixation (any one of the paracentral points with sensitivity less than 10dB); inability to perform reliable VF; suboptimal quality of SDOCT images (see SDOCT imaging); previous intraocular surgery other than uncomplicated cataract extraction; and diabetic retinopathy/maculopathy.

Age minimum: 18
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Glaucoma

Intervention(s)

Intervention vs control:Using additional eye drops and/or laser procedure to achieve 20% intraocular pressure (IOP) lowering from baseline. Drug: prostaglandin analogue, brimonidine and carbonic anhydrase inhibitor Procedure: Selective Laser Trabeculoplasty versus continue the current treatment (observation or one topical IOP lowering medication) started before recruitment (see Inclusion Criteria).;

Primary Outcome(s)

Proportion of eyes with VF progression;

Secondary Outcome(s)

Proportion of eyes with RNFL progression;Rate of change visual field index;Rate of change of LC deformation before and after IOP reduction;Risk factors of LC deformation;

Secondary ID(s)

CUHK_CCT00439

Source(s) of Monetary Support

Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong

Ethics review

Status: Approved
Approval date: 10/11/2014
Contact:

Kowloon Central Cluster REC / Kowloon East Cluster REC