| 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
|
|
|
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
|
|
|
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. |