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CTRI Number  CTRI/2025/10/096447 [Registered on: 24/10/2025] Trial Registered Prospectively
Last Modified On: 24/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To Examine Safety and Efficacy of 525nm Multispot Green Laser and compare It with 532nm Multispot Green Laser In Retinal Disorders 
Scientific Title of Study   A Prospective Comparative Study To Evaluate The Safety And Efficacy Of Aurolab’s Multispot Green Laser 525nm vs Iridex’s Pascal’s (532nm) Multispot Green Laser In Photocoagulation In Retinal Disorders 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr A Syed Mohideen Abdul Khadar MS  
Designation  Senior Consultant, Head of Department, Retina Vitreous Services 
Affiliation  Aravind Eye Hospital 
Address  Aravind Eye Hospital, 203, A Block, Department of Retina and Vitreous Services, Swami Nellaiappar High Rd, Vannarpettai, Tirunelveli, Tamil Nadu 627001 India

Tirunelveli
TAMIL NADU
627001
India 
Phone  9894849765  
Fax    
Email  syedmohideen@aravind.org  
 
Details of Contact Person
Scientific Query  
Name  Dr A Syed Mohideen Abdul Khadar MS  
Designation  Senior Consultant, Head of Department, Retina Vitreous Services 
Affiliation  Aravind Eye Hospital 
Address  Aravind Eye Hospital, 203, A Block, Department of Retina and Vitreous Services, Swami Nellaiappar High Rd, Vannarpettai, Tirunelveli, Tamil Nadu 627001 India


TAMIL NADU
627001
India 
Phone  9894849765  
Fax    
Email  syedmohideen@aravind.org  
 
Details of Contact Person
Public Query  
Name  Dr A Syed Mohideen Abdul Khadar MS  
Designation  Senior Consultant, Head of Department, Retina Vitreous Services 
Affiliation  Aravind Eye Hospital 
Address  Aravind Eye Hospital, 203, A Block, Department of Retina and Vitreous Services, Swami Nellaiappar High Rd, Vannarpettai, Tirunelveli, Tamil Nadu 627001 India


TAMIL NADU
627001
India 
Phone  9894849765  
Fax    
Email  syedmohideen@aravind.org  
 
Source of Monetary or Material Support  
Aurolab 
 
Primary Sponsor  
Name  Aurolab 
Address  No.1 Sivaganga Rd,Veerapanjan, Madurai 625020 Tamil Nadu, India 
Type of Sponsor  Other [Trust] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr A Syed Mohideen Abdul Khadar MS  Aravind Eye Hospital  203, A Block, Department of Retina and Vitreous Services, Swami Nellaiappar High Rd, Vannarpettai, Tirunelveli, Tamil Nadu 627001 India
Tirunelveli
TAMIL NADU 		 9894849765

syedmohideen@aravind.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Aravind Eye Hospital, Tirunelveli  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H356||Retinal hemorrhage,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  525nm Multispot Green Laser  An ophthalmic Multispot green laser system designed to emit a 525nm wavelength for photocoagulation. Delivers a stable and accurate 525nm wavelength output, enabling seamless integration with slit lamps, indirect ophthalmoscopes, and Endo probes to seal leaky blood vessels in the eye also in diabetic retinopathy, retinal vein occlusion to stop the progression of the disease  
Comparator Agent  532nm Multispot Green Laser  Multispot green laser uses a high energy light beam (525nm) to destroy or shrink abnormal structures, such as leaky blood vessels, in the eye. This procedure is used to treat conditions like diabetic retinopathy, retinal vein occlusion to stop the progression of the disease and prevent further vision loss. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients more than 18 years of age
2.Clear Cornea
3.Clear intraocular media
4.Intraocular pressure less than 20 mmHg
5.Well dilating pupil
6.Both eyes with clear proliferative Diabetic Retinopathy requiring laser photocoagulation
7.Patients willing to give written consent
8.Patients willing to come for follow up 
 
ExclusionCriteria 
Details  1.Advanced PDR
2.Clinically Significant Macular Edema (CSME)
3.Nephropathy (Creatinine greater than 2.0 mgs, Urea greater 55 mgs)
4.Uncontrolled hypertension
5.Patients require more than two sessions of laser photocoagulation.
6.Patients who had undergone previous laser photocoagulation
7.Patients who have undergone any previous vitreoretinal surgery
8.Eyes with media opacities not allowing proper fundus photography or adequate laser photocoagulation (Cataract, Corneal opacity, Dense vitreous hemorrhage, etc.,)
9.Those who are not willing for examinations, laser treatment and follow up visits.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Regression of retinopathy, pigmentation of burn,
visual outcome after PRP laser treatment 		 Preop
Day 15 post operatively
Day 30 post operatively
Day 90 post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
1.Visual outcome after PRP laser treatment
2.No lateral spreading and collateral damage, pain score 		 0
Day 15
1 Month
3 Month 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/11/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Photocoagulation laser is an eye treatment that uses a high energy light beam to destroy or shrink abnormal structures, such as leaky blood vessels, in the eye. This procedure is commonly used to treat conditions like diabetic retinopathy, retinal vein occlusion, and wet-type age-related macular degeneration to stop the progression of the disease and prevent further vision loss. While it doesn’t restore vision that is already lost, it can help prevent more severe vision loss. It is an outpatient procedure that can take about few minutes to complete the laser session. The device used in this study is designed to treat similar conditions. 
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