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Natural History of Primary Angle Closure Disease

Risk of Progression In Incident Versus Prevalent Gonioscopic Angle Closure - IPAC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/032311
Enrollment
2400
Registered
2021-03-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H400- Glaucoma suspect

Interventions

Intervention1: Laser Peripheral Iridotomy: In Bilateral Primary Angle Closure Suspects, one eye of the patient will undergo Laser Peripheral Iridotomy at random. This eye will be compared with the fel

Sponsors

Massachusetts Eye and Ear Infirmary
Lead Sponsor
Aravind Eye Hospital Pondicherry and Tamil Nadu
Collaborator

Eligibility

Inclusion 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) Found to have narrow angles/shallow anterior chamber (defined as a van Herick grade

Exclusion criteria

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 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 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 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

Design outcomes

Primary

MeasureTime frame
Progression to incident angle closure among high risk open angle eyes 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 Intraocular pressure changes from baseline for primary angle closure suspects and high risk open angle eyes, calculated at specified time points Timepoint: 2, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

Secondary

MeasureTime frame
Progression to primary angle closure/Primary angle closure glaucoma among primary angle closure suspects eyes with and without Laser peripheral iridotomy 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]) Timepoint: 2, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

Countries

India

Contacts

Public ContactDr S Kavitha

Aravind Eye Hospital Pondicherry

skavitha.shree@gmail.com9894611575

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026