This study is to evaluate the anesthetic pain and discomfort during retinal photocoagulation.

Completed

• Registration Number: CTRI/2018/04/013173
• Lead Sponsor: Giridhar Eye Institute

Brief Summary

**Introductin**

Laser photocoagulation or retinopexy is a common form of treatment used to manage a large variety of retinal disorders such as occlusive retinovascular diseases and peripheral retinal breaks. This is typically perormed using a laser delivery system mounted to a biomicriscope or an indirect ophthalmoscope, with the aid of a contact lens or condensing lens respectively, the laser beam is focused onto the patient’s retina to create a visible white retinal burn that will eventually result in a chorioretinal scar, which treats the disorder. Pan Retinal Photocoagulation is an effective treatment in reducing severe visual loss in patients with proliferative diabetic retinopathy. The diabetic retinopathy study recommended that treatment consists of 800-1600 argon laser burns of 500 mm size to the peripheral retina in a scatter fasion. However, previous studies have shown that PRP is a painful procedure for most patients. The pain is caused by the stimulation of pain receptors in the sclera when a retinal laser burn is induced, and this has been reported to occur in up to 73% of patients. Therefore, to reduce patient suffering during PRP some pain-relieving procedures are necessary when performing PRP. There are several options to reduce pain associated with PRP performed on an outpatient basis. Retrobulbar anaesthesia, peribulbar anaesthesia and sub tenon anaesthesia are effective pain relieving procedures but are invasive for patients with potential complications.



**Aim of the Study** is to evaluate the efficacy of sub conjunctival anesthesia for pain and discomfort during retinal photocoagulation and to assess whether it helps to reduce time duratin of the procedure.



**Materials and Methods**: This is a single-center, prospective, randomized controlled trial.

Total of 30 patients (60 eyes).

30 eyes in one group



**Consent** will be taken. After a test dose of lignocaine, patient will be given subconjunctival lignocaine 0.5 ml in one eye and sham injection in the other eye using random allocation software. PRP will be performed in both eyes.



A questionnaire to describe comfort level, presence, intensity and type of pain will be given to the patients at the end of the procedure. This will be recorded using a numerical pain assisting procedure. Laser parameters that were recorded included power settings, number of burns, and method of laser delivery.



Results will be statistically analysed.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-25
• Study Completion: 2013-01-13
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Proliferative Diabetic Retinopathy patients posted for Pan Retinal Photocoagulation in both eyes.

Exclusion Criteria

• Recent history (less than one month) of ocular surgery in any one eye.
• Allergy to Lignocaine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Pain.	Incidence of Pain.

Secondary Outcome Measures

Name	Time	Method
Time duration of the procedure	Severity of pain

Trial Locations

Locations (1)

Giridhar Eye Institute; 🇮🇳 Ernakulam, KERALA, India

Giridhar Eye Institute

🇮🇳Ernakulam, KERALA, India

Dr Rameez N Hussain

Principal investigator

9444527891

dr.rameezhussain@gmail.com