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

Not Applicable

• Conditions: Health Condition 1: H350- Background retinopathy and retinalvascular changes

• Registration Number: CTRI/2024/01/061171
• Lead Sponsor: Dr Arpit Gupta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br/ ><br> <br/ ><br>1) 15 minutes before the procedure <br/ ><br> <br/ ><br>2) immediately after the procedure of 1st eye <br/ ><br> <br/ ><br>3) immediately after the procedure of the 2nd eye <br/ ><br> <br/ ><br>4) 15 minutes post-procedure of 2nd eyes

Secondary Outcome Measures

Name	Time	Method
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 <br/ ><br> <br/ ><br>1) 15 minutes before the procedure <br/ ><br> <br/ ><br>2) immediately after the procedure of 1st eye <br/ ><br> <br/ ><br>3) immediately after the procedure of the 2nd eye <br/ ><br> <br/ ><br>4) 15 minutes post-procedure of 2nd eyes;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 <br/ ><br> <br/ ><br>1) 15 minutes before the procedure <br/ ><br> <br/ ><br>2) immediately after the procedure of 1st eye <br/ ><br> <br/ ><br>3) immediately after the procedure of the 2nd eye <br/ ><br> <br/ ><br>4) 15 minutes post-procedure of 2nd eyes