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To study the patient experience during the Pan-retinal laser procedure and compare two different laser modalities

: A randomised comparative study of anxiety and perceived pain in patients undergoing pan-retinal photocoagulation for proliferative diabetic retinopathy â?? a comparison between two different laser delivery systems. - Not applicable

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/01/061171
Enrollment
350
Registered
2024-01-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: H350- Background retinopathy and retinalvascular changes

Interventions

Intervention1: NIL: NIL

Sponsors

Dr Arpit Gupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with Proliferative diabetic Retinopathy requiring Pan-retinal photocoagulation for the first time in the management of both eyes. 2. Treatment naive eyes

Exclusion criteria

Exclusion criteria: 1. Patients below 18 Years of age 2. Patients on anxiolytic drugs prior to the surgery 3. Patients with a known history of psychiatric illness or on treatment for the same. 4. Patients with hearing impairment and speech disorders. 5. Pregnant women 6. Vitreous haemorrhage 7. Patients undergoing PRP for indications other than PDR, like Vasculitis or vein occlusion. 8. Patient undergoing any Laser procedure other than PRP.

Design outcomes

Primary

MeasureTime frame
To study the anxiety (using PAS-7 and VAS-A) and pain (using VAS-P) experienced by patients undergoing pan-retinal photocoagulation for PDRTimepoint: Parameters will be measured at following intervals 1) 15 minutes before the procedure 2) immediately after the procedure of 1st eye 3) immediately after the procedure of the 2nd eye 4) 15 minutes post-procedure of 2nd eyes—

Secondary

MeasureTime frame
To compare patient experience in terms of pain and anxiety between different delivery methods (LIO and PASCAL) and different sittings (first and second) for the pan-retinal photocoagulation procedure.Timepoint: Parameters will be measured at following intervals 1) 15 minutes before the procedure 2) immediately after the procedure of 1st eye 3) immediately after the procedure of the 2nd eye 4) 15 minutes post-procedure of 2nd eyes;To assess objective indicators of stress or anxiety (by measuring vital parameters) in patients undergoing pan-retinal photocoagulation procedureTimepoint: Parameters will be measured at following intervals 1) 15 minutes before the procedure 2) immediately after the procedure of 1st eye 3) immediately after the procedure of the 2nd eye 4) 15 minutes post-procedure of 2nd eyes—

Countries

India

Contacts

Public ContactDr Arpit Gupta

Aravind eye Hospital, Pondicherry

manavi@aravind.org9884081417

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026