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CTRI Number  CTRI/2024/05/068093 [Registered on: 30/05/2024] Trial Registered Prospectively
Last Modified On: 29/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Randomised Control Trial To Compare Central Macular Thickness(Retinal thickness) in Patients Undergoing Phacoemulsification(Phaco Cataract surgery) with or without Intravitreal Dexamethasone(steroid) Injection in Patients with Coexisting Diabetic Macular Edema(fluid in retina due to Diabetes) 
Scientific Title of Study   To Compare Central Macular Thickness in Patients Undergoing Phacoemulsification with or without Intravitreal Dexamethasone Injection in Patients with Coexisting Diabetic Macular Edema 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arnav Singhal 
Designation  post MBBS DNB 
Affiliation  Northern Railway Central Hospital 
Address  Room number 4 Department of Ophthalmology ground floor Northern Railway Central Hospital Basant Lane Aram Bagh Paharganj New Delhi

Central
DELHI
110055
India 
Phone  9717565748  
Fax    
Email  singhalarnavbunny@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. SK Choudhary 
Designation  Assistant Chief Health Director 
Affiliation  Northern Railway Central Hospital 
Address  Room number 4 Department of Ophthalmology ground floor Northern Railway Central Hospital Basant Lane Aram Bagh Paharganj New Delhi

Central
DELHI
110055
India 
Phone  9717630563  
Fax    
Email  SHAILENDERCHOUDHARY@REDIFFMAIL.COM  
 
Details of Contact Person
Public Query
 
Name  Dr. SK Choudhary 
Designation  Assistant Chief Health Director 
Affiliation  Northern Railway Central Hospital 
Address  Room number 4 Department of Ophthalmology ground floor Northern Railway Central Hospital Basant Lane Aram Bagh Paharganj New Delhi

Central
DELHI
110055
India 
Phone  9717630563  
Fax    
Email  SHAILENDERCHOUDHARY@REDIFFMAIL.COM  
 
Source of Monetary or Material Support  
Room number 4 Department of Ophthalmology ground floor Northern Railway Central Hospital Basant Lane Aram Bagh Paharganj New Delhi 
 
Primary Sponsor  
Name  Northern Railway Central Hopital 
Address  Room number 4 Department of Ophthalmology Ground floor Northern Railway Central Hospital Basant Lane Aram Bagh Paharganj New Delhi 110055 India 
Type of Sponsor  Research institution and hospital 
 
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 Arnav Singhal  Northern Railway Central Hospital  Room number 4 Department of Ophthalmology ground floor Northern Railway Central Hospital Basant Lane Aram Bagh Paharganj New Delhi 110055 India
Central
DELHI 
9717565748

singhalarnavbunny@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NORTHERN RAILWAY CENTRAL HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravitreal Dexamethasone injection post Phacoemulsification  Post the Phacoemulsification Lignocaine will be instilled topically. A distance of 3.5mm shall be marked from limbus in the infratemporal quadrant. A 0.05 ml dose of intravitreal Dexamethasone will be injected into vitreous cavity by 30 gauge needle under microscopic visualization.  
Comparator Agent  Phacoemulsification without intravitreal Dexamethasone injection  Phacoemulsification will be performed on each patient and then they will be kept under observation without giving intravitreal Dexamethasone injection. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1.Type 1 and 2 Diabetes Mellitus.
2.Visual Acuity of 6/12 or less.
3.Central macular thickness of 300 microns or less.
4.Any gender. 
 
ExclusionCriteria 
Details  1 Any co-existing retinal pathology apart from diabetic retinopathy likely to affect visual acuity.
2 Vitrectomised Eye.
3 Uncontrolled Diabetes defined of HbA1c more than 10 percent.
4 Any intra operative or post-operative complication effecting the visual acuity.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare change in central macular thickness by OCT   1 week 1 month 2 months and 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
To compare change in intraocular pressure by NCT following the procedure   at 1 week, 1 month, 2 months and 3 months follow up. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 3 
Date of First Enrollment (India)   09/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Phacoemulsification will be performed on each patient, and IOL placement was aided. Every surgery will be performed under 4% lignocaine topical anesthesia. The patient receives eye drops (ophthalmic solution containing gatifloxacin and prednisolone) prior to surgery. The patient will be given eye drops (tropic amide 0.8% and phenylephrine 5% w/v) to dilate their pupils on the day of surgery. The conjunctival sac is injected with one drop of a 5% povidone- iodine solution to eradicate the local saprophytic microbiological flora. After cleaning, the patient’s eye will be covered. A clear corneal incision (1 mm anterior to the limbus) will be made, and one entryon a steep axis using a 2.8 mm keratome was made using a 15 degree lance tip (side port blade) into the anterior chamber (AC). In order to stain the anterior capsule, AC was injected with 0.06% trypan blue dye. The dye will be washed out with BSS (Balanced Salt Solution). Viscoelastic 1% sodium hyaluronate will injected to form AC, followed by anterior continuous curvilinear capsulorhexis with a capsulotomy needle.

After that, the anterior chamber will decompress, and hydro delineation and hydro dissection will be completed. A 2% hydroxypropyl methylcellulose viscoelastic substance is applied to the corneal endothelium, and the (STELLARIS, B & L) phacoemulsification system will be used to phacoemulsify the nucleus. Next, a co-axial/bimanual irrigation-aspiration probe will be used to aspirate the cortical matter. After adding sodium hyaluronate viscoelastic to the capsular bag, a single-piece foldable hydrophilic four haptic IOL (Bausch n Lomb) will be placed inside of it. Using an irrigation aspiration probe, the viscoelastic was removed, and the surgery was concluded by hydrating the entry wounds with BSS. The eye is closed using 0.5 moxifloxacin eye drops once the integrity of the wound has been confirmed. Post the phacoemulsification of the concerned eye, the concerned eye will be cleaned and draped. Lignocaine 4% will be instilled topically. A distance of 3.5mm shall be marked from limbus inthe infratemporal quadrant. A 0.05 ml dose of intravitreal Dexamethasone will be injected into vitreous cavity by 30 gauge needle under microscopic visualization.Then central macular thickness by OCT, intra ocular pressure by NCT and intra opeartive complications would be compared.

All the above parameters would be noted at baseline day7, day30, day60, day90 following the injection into the vitreous cavity by a regular faculty in ophthalmology.


If      during the      follow up      any      complication occurs-Iritis     (inflammation of iris), Vitritis (inflammation of vitreous), Retinal vasculitis (inflammation of retinal veins and arteries) then the patient will be managed accordingly with anti-inflammatory agents.

If any of the patient develops Retinal venous occlusion, vitreous hemorrhage, endophthalmitis, Retinal detachment or lens injury then patient will be excluded from the study and will be managed by expert consultant accordingly.

 
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