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SHARP study - A counselling study for high risk cases

Subjective High-risk pAtient counselling Randomisation Project (SHARP) - SHARP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/016910
Enrollment
3000
Registered
2019-01-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: H353- Degeneration of macula and posterior pole Health Condition 2: H330- Retinal detachment with retinal break Health Condition 3: H36- Retinal disorders in diseases classified elsewhere

Interventions

Intervention1: Emotional videos: Patient will be shown an emotional video showing impact of not receiving treatment. They will also receive routine counseling. The follow up of this patient will be tr

Sponsors

Aravind eye Hospital Pondicherry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The inclusion criteria are: 1.The patient must be either an E1 or E2 patient. 2. PDR - E1 - those meeting high risk characteristics (HRPDR) as per ETDRS classification. E2 - those with PDR as per ETDRS classification. At least one eye should fulfill either E1 or E2 criteria and be suitable for 1,2 or 3 sittings of laser. 3. RD - E1- Rhegmatogenous retinal detachment, undergoing vitrectomy with - onset less than 2 weeks, retinal detachment with macula on/attached, giant retinal tears, retinal detachment with choroidal detachment. E2- all other rhegmatogenous retinal detachments. Retinal detachments undergoing scleral buckling will also be included. 4.AMD â?? E2- All cases of age related macular degeneration scheduled to receive intravitreal anti-VEGF agents. New as well as review cases will be included. Number of prior injections will be noted.

Exclusion criteria

Exclusion criteria: Exclusion criteria : 1. Any retina patient who does not meet the inclusion criteria. 2. Minors with above conditions. 3. Retinal detachment cases wherein the surgeon expects very poor anatomical outcomes, and patient may be given the choice to opt out of any intervention by the examining doctor, e.g. very long standing retinal detachments, those as a result of trauma with very poor prognosis.

Design outcomes

Primary

MeasureTime frame
The extent to which showing emotional or technical videos make a difference in the follow up rate of E1 and E2 patients, and the extent to which financial incentives motivate those who fail to show up in the prescribed time period. In addition, it will generate fundamental insights regarding patient behaviors.Timepoint: The interim results will be assessed every 6 months, till completion of trial. Final outcomes will be measured at conclusion of trial.

Secondary

MeasureTime frame
The extent to which financial incentives help to bring back lost to follow-up casesTimepoint: Within treatment duration - if fail to return for appointment in 1-2 days

Countries

India

Contacts

Public ContactDr Manavi D Sindal

Aravind Eye Hospital and Postgraduate institute of Ophthalmology

manavi@pondy.aravind.org9884081417

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026