atural History of Primary Angle Closure Disease

Not Applicable

• Conditions: Health Condition 1: H400- Glaucoma suspect

• Registration Number: CTRI/2021/03/032311
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression to incident angle closure among high risk open angle eyes <br/ ><br> <br/ ><br>Progression to primary angle closure/primary angle closure glaucoma among incident angle closure vs primary angle closure suspect eyes that have not undergone laser peripheral iridotomy <br/ ><br> <br/ ><br> <br/ ><br>Intraocular pressure changes from baseline for primary angle closure suspects and high risk open angle eyes, calculated at specified time points <br/ ><br>Timepoint: 2, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

Secondary Outcome Measures

Name	Time	Method
Progression to primary angle closure/Primary angle closure glaucoma among primary angle closure suspects eyes with and without Laser peripheral iridotomy <br/ ><br> <br/ ><br>Progression to primary angel closure/primary angle closure glaucoma among primary angel closure suspect eyes post-Laser peripheral iridotomy with and without persistent angle closure (defined as � 180° degrees occludable drainage angles without visible posterior trabecular meshwork [TM]) <br/ ><br>Timepoint: 2, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months