FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/068825 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 27/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   An interventional study to evaluate the use of imaging tool during diabetic retinal (inner layer of eye) detachment surgery to reduce the risk of re-surgery 
Scientific Title of Study   Use of microscopic integrated optical coherence tomography to reduce post-surgical epiretinal membrane formation in eyes undergoing vitrectomy for tractional retinal detachment due to diabetic retinopathy. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DIVYA CHAUHAN 
Designation  MCH SENIOR RESIDENT 
Affiliation  Post graduate institute of medical education and research, Chandigarh  
Address  Room number 223, Retina and Uvea services, Department of Ophthalmology, Advanced eye centre, Post graduate institute of medical education and research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9805869879  
Fax    
Email  divacn77@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ramandeep Singh 
Designation  Professor 
Affiliation  Post graduate institute of medical education and research, Chandigarh 
Address  Room number 112, Advanced eye centre, Post graduate institute of medical education and research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9463001620  
Fax    
Email  ramandeeppgi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ramandeep Singh 
Designation  Professor 
Affiliation  Post graduate institute of medical education and research, Chandigarh 
Address  Room number 112, Advanced eye centre,Post graduate institute of medical education and research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9463001620  
Fax    
Email  ramandeeppgi@gmail.com  
 
Source of Monetary or Material Support  
Advanced eye centre, Post graduate institute of medical education and research,Chandigarh, 160012, India 
 
Primary Sponsor  
Name  Advanced Eye Centre 
Address  Advanced Eye Centre, PGIMER, Vidya Path, sector 12, Chandigarh, 160012 
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 
Divya Chauhan  Post graduate institute of medical education and research, Chandigarh  Room number 112, advanced eye centre, Post graduate institute of medical education and research,sector 12, Chandigarh
Chandigarh
CHANDIGARH 
9805869879

divacn77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee (Intramural) PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard vitrectomy and ILM peeling without the use of microscopic integrated optical coherence tomography will be done  Standard removal of internal limiting membrane without the use of microscopic integrated optical coherence tomography to evaluate the incidence of post operative membrane formation. Patients will be followed up at day 1, day 30 and day 90. It will be a one time intervention.  
Intervention  Use of microscopic integrated optical coherence tomography to reduce post-surgical epiretinal membrane formation in eyes undergoing vitrectomy for tractional retinal detachment due to diabetic retinopathy   ILM peeling with the use of microscopic integrated optical coherence tomography to evaluate the incidence of post operative membrane formation. Patients will be followed up at day 1, day 30 and day 90. It will be a one time intervention.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  type 1 and 2 DM who require vitrectomy for diabetic TRD
willing for preoperative injection of Ranibizumab
phakic or pseudophakic
willing for follow up period of 3 months 
 
ExclusionCriteria 
Details  aphakic patients
NVI/NVG
history of prior vitrectomy
combined retinal detachment
requiring silicone oil tamponade in case of intraoperative break formation
unwilling for preoperative injection of Ranibizumab
history of stroke/MI 3 months before injection of Ranibizumab
unable to maintain a particular posture after surgery, if required
unwilling to be a part of the study 
 
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, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
we will compare the incidence of epiretinal membrane formation between group A and group B
group A- MIOCT will be used at the end of surgery to look for preretinal residual membranes. They will be removed intraoperatively using MIOCT.
group B- conventional ILM peeling group 
day 1, 1 week, 1 month and at 3 months. 
 
Secondary Outcome  
Outcome  TimePoints 
comparison of visual gain and any complications such as postoperative vitreous cavity haemorrhage between the two groups  at 3 months 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   01/07/2024 
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="0"
Months="9"
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  

Post-surgery epiretinal membrane formation (ERM) is a frequent complication associated with pars plana vitrectomy. Diabetic retinopathy poses an independent risk factor for the development of ERM. Despite extensive vitrectomy and membrane peeling, the incidence of postoperative ERM was found to be 21.7–52.8%.  

It has been suggested that ILM peeling can reduce ERM production and diabetic macular edema in diabetic eyes. The introduction of microscope integrated optical coherence tomography (MIOCT) is reported to provide valuable inputs peculiarly during identification of dissection plane, membrane peeling, identification of residual membranes and underlying epiretinal membranes.  

Ours will be a prospective, randomized, interventional study. All patients presenting to AEC, PGIMER, Chandigarh with diagnosis of diabetic TRD threatening or involving macula will be included in the study, after obtaining written informed consent. The study will be following the Declaration of Helsinki guidelines for research involving human subjects. 

Patients fulfilling the inclusion criteria will be recruited for the study after written informed consent and will be randomized into 2 groups by a coin toss on the day before surgery. Heads= group A, Tails = group B. The surgeon will be blinded from the pre-operative and post-operative details, and the person performing analysis will be separate from the operating team and clinical team.  

All the surgeries will be done by a single surgeon with more than 18-years’ experience in vitreoretinal surgery. All patients will receive preoperative ranibizumab intravitreal injection 3 to 5 days prior to surgery. In Group A patients, MIOCT will be used to look for the preretinal membranes in the macular area at the end of surgery to look for preretinal residual membranes. They will be removed intraoperatively using MIOCT. While Group B patients will undergo ILM peeling (2 disc diameter) using BBG staining (0.25mg/ml) followed by immediate washout to make sure that all preretinal membranes have been removed. We will be using laser photocoagulation and/or cryotherapy at port sites, and internal tamponade with air or gas depending on the intraoperative requirements.  

Follow up of each patient will be done at postoperative day 1, 1 week, 1 month and at 3 months. At each follow up patients are subjected to BCVA measurement, IOP measurement, anterior and posterior segment examination. Media clarity, retina status and presence of post-operative vitreous cavity haemorrhage (POVCH) will be documented. 

There is lack of comparative and randomized study, comparing the role of MIOCT and ILM peeling to prevent post-surgery ERM formation in TRD eye of diabetes patients undergoing PPV. In this study, we will evaluate the role of MIOCT to reduce post-surgical ERM in eyes undergoing PPV for TRD due to diabetic retinopathy. 

 
Close