An Ophthalmic Surgical Knives study to assess clinical performance and safety in patients undergoing cataract surgery.

Not Applicable

Active, not recruiting

• Conditions: Age-related nuclear cataract,

• Registration Number: CTRI/2022/08/044920

Brief Summary

Purpose of the study is to assess clinical performance, efficacy and safety of a device when used in accordance with its approved labelling. These may examine issues such as medium-term performance, the appearance of clinical events, events specific to defined patient populations, or the performance of the device in a more representative population of providers and patients with cataract.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-30
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Age 18 year or greater 2.
• Cataract of any kind 3.
• Patient willing to participate and sign informed consent to participate in study and to use device related data for scientific purpose 4.
• Patient willing to come for all post-operative follow-up 5.
• Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.

Exclusion Criteria

• Received (or is planning to receive) anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs [oral/ injectable corticosteroids or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)], or other substances known to increase coagulation time from 10 days pre- to 3 days post injection 2.
• Traumatic cataract 3.
• Pregnancy (as stated by patient) or lactation 4.
• Concurrent participation in another drug or device investigation.
• Patient receiving chloroquine treatment 6.
• Subjects with any systemic and metabolic disease that could increase operative risk or confound the outcome 7.
• Vulnerable subjects 9.
• Patient having Microphthalmia 10.
• Patient having chronic uveitis 11.
• Patient suffering from Corneal dystrophy or endothelial insufficiency 12.
• Patient having active ocular diseases (active diabetic retinopathy, uncontrolled glaucoma) 13.
• Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study 14.
• Patient who sensitive or allergic to metals.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evaluated by overall surgeon satisfaction score in terms of	Intra-Operative, Post-Operative | day 1 & day 30.
following parameters [Time Frame: Intra-Operative]	Intra-Operative, Post-Operative | day 1 & day 30.
The sharpness of blade, ease of handling the blade, smoothness of	Intra-Operative, Post-Operative | day 1 & day 30.
incision creation, control while creating the wound.	Intra-Operative, Post-Operative | day 1 & day 30.
The mean performance of both ophthalmic knives will be	Intra-Operative, Post-Operative | day 1 & day 30.

Secondary Outcome Measures

Name	Time	Method
1) Wound integrity	2) Incision size accuracy

Trial Locations

Locations (1)

Dr. Agarwals Eye Hosptial; 🇮🇳 Tirunelveli, TAMIL NADU, India

Dr. Agarwals Eye Hosptial

🇮🇳Tirunelveli, TAMIL NADU, India

Prof Dr Lional Raj D

Principal investigator

8754411261

drlionalraj@dragarwal.com