| CTRI Number |
CTRI/2018/05/014219 [Registered on: 30/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
16/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of retinal architectural changes using intraoperative optical coherence tomography in macular hole surgery- a prospective randomized trial |
|
Scientific Title of Study
|
Comparative evaluation of retinal architectural changes using intraoperative microscope integrated i-OCT in macular hole surgery-a prospective randomized trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
LOHITH RAMBARKI |
| Designation |
Junior Resident |
| Affiliation |
Dr. Rajender Prasad center for ophthalmic sciences |
| Address |
room no 485
4th floor
Dr. Rajender Prasad centre for Ophthalmic sciences
New Delhi
South
DELHI
110029
India |
| Phone |
9971532113 |
| Fax |
|
| Email |
lohithmedico06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ATUL KUMAR |
| Designation |
CHIEF, PROFESSOR IN OPHTHALMOLOGY |
| Affiliation |
Dr. Rajender Prasad center for ophthalmic sciences |
| Address |
room no 485
4th floor
Dr. Rajender Prasad centre for Ophthalmic sciences
New Delhi
South
DELHI
110029
India |
| Phone |
9810081996 |
| Fax |
|
| Email |
atul56kumar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Lohith Rambarki |
| Designation |
Junior Resident |
| Affiliation |
Dr. Rajender Prasad center for ophthalmic sciences |
| Address |
room no 485
4th floor
Dr. Rajender Prasad centre for Ophthalmic sciences
New Delhi
South
DELHI
110029
India |
| Phone |
9971532113 |
| Fax |
|
| Email |
lohithmedico06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Rajendra Prasad Center for Ophthalmic Sciences,AIIMS |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Center For Ophthalmic Sciences |
| Address |
Room no 485
4th floor
Dr.Rajender Prasad Center for ophthalmic sciences
NewDelhi |
| 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 |
| Lohith Rambarki |
Dr. Rajendra Prasad Center For Ophthalmic Sciences |
Ansari nagar
New delhi
South West
DELHI |
9971532113
lohithmedico06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POSTDRADUATE RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients having diabetes mellitus type2, hypertension , hypo/hyperthyroidism were also included, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intraperative Optical Coherence Tomography
comparative agent - not appicable |
OCT takes images and will do analysis of data. it is microscope integrated.Rescan,Opera microscope and Callisto fundus viewing system are the components. image _j software was used in this study for analysing images. |
| Comparator Agent |
not applicable |
not appicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Primary idiopathic macular holes stage 3 and stage 4;Pseudophakic or phakic eyes;No other relevant pathology like AMD, Diabetic maculopathy, trauma etc;Healthy optic nerve
|
|
| ExclusionCriteria |
| Details |
Patients with stage 1 and stage 2 macular holes, Traumatic /secondary macular hole and recurrent holes were excluded. Patients having any macular pathology and previously vitrectomized were not included. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual acuity
anatomical closure |
Visual acuity
anatomical closure
postoperative 1st day,1st week,1 month,3months,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Distance between Ellipsoid zone and RPE band |
postoperatively 1st day,1st 1week, 1st month, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2016 |
| Date of Study Completion (India) |
30/03/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
macular hole occurs in elderly patients. larger macular hole can be treated surgically only. In this study we have done macular hole surgery with inverted flap ILM peeling technique using intraoperative microscope integrated OCT in 20 patients. we have recruited patients for period of 18 months. Postoperatively patients were followed on 1st day, 1st week,1st month, 3 months, 6 months. Routine inestigations along with OCT were performed in routine followup.
|