CTRI/2021/03/032311Not yet recruiting未知
Risk of Progression In Incident Versus Prevalent Gonioscopic Angle Closure - IPAC
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Primary Angle Closure Suspect (PACS) >=180° degrees of occludable drainage angles without visible posterior trabecular meshwork [TM] Participants in the PACS group will need to meet criteria for PACS in both eyes
- •High Risk Open Angles (HROA) Individuals who have at least one eye open on gonioscopy (visible pigment TM>=270) who meet one of the following criteria
- •First-degree relatives of patients with Primary Angle Closure (PAC) / Primary Angle Closure Glaucoma (PACG)
- •Hyperopic by at least +2D and a corrected anterior chamber depth (cACD) <3 mm on optical biometry in at least one eye
- •Found to have narrow angles/shallow anterior chamber (defined as a van Herick grade <=2) and a cACD <3 mm on optical biometry in at least one eye
Exclusion Criteria
- •Primary Angle Closure Suspect (PACS) participants will be excluded if they meet exclusion criteria in any eye. High Risk Open Angle (HROA) participants will be excluded if they meet exclusion criteria in the eye meeting HROA inclusion criteria.
- •Individuals <40 years of age
- •Individuals without capacity to consent/neuro cognitive disorders.
- •Presence of Peripheral Anterior Synechia (PAS), localized hyperpigmentation or other findings suggesting obstruction of Trabecular Meshwork (TM)
- •Intraocular Pressure (IOP) by Goldmann Applanation Tonometry >= 22 per Ocular Hypertension Treatment Study (OHTS) protocol12 (see methodology section). IOP will be measured at 2-month follow-up. The average of the baseline and 2-month follow-up IOP will be calculated. If the average is >=22, the participant will be excluded.
- •Evidence of glaucomatous optic neuropathy on examination according to the International Geographical and Epidemiological Ophthalmology (ISGEO) classification of glaucoma13:
- •Category 1 (structural and functional evidence): Vertical Cup Disc Ratio (VCDR) >=0.7, VCDR asymmetry >=0.2 or neuroretinal rim width <= 0.1 Cup Disc Ration (CDR) and definite Visual Field (VF) defect. No alternative explanation for CDR or VF findings.
- •Category 2 (advanced structural damaged with unproved field loss): VCDR >=0.85, VCDR asymmetry >=0.25 and incomplete VF. No alternative explanation for CDR findings.
- •Category 3 (Optic disc not seen. Field test impossible): IOP >=22 mm Hg and 3/60 visual acuity or visual acuity <3/60 and glaucoma surgery or documented history of glaucoma.
- •Visually significant cataract
- •Pseudophakia
- •Previous glaucoma laser or incisional surgery
- •Signs or symptoms of acute angle closure attack in any eye
- •Evidence of secondary glaucoma, other vision-threatening retinal pathology or systemic disease requiring frequent dilation, such as diabetic retinopathy and age-related macular degeneration.
- •Visual acuity <20/40
Investigators
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