| 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
|
|
|
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
|
|
|
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.
|