| CTRI Number |
CTRI/2020/04/024718 [Registered on: 17/04/2020] Trial Registered Prospectively |
| Last Modified On: |
09/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of conventional and newer methods of axial length measurement in silicone oil filled eyes. |
|
Scientific Title of Study
|
Comparison of Optical biometry and Conventional acoustic biometry in the axial length measurement in silicone oil filled eyes. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Da Cruz Russell Mark |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 101, First floor, Department of Ophthalmology, Guru Nanak Eye Centre, Maharaja Ranjit Singh Marg, New Delhi.
Central
DELHI
110002
India |
| Phone |
9765323120 |
| Fax |
|
| Email |
rdacruz@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi Thakar |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room Number 103, 1st Floor, OPD Block, Guru Nanak Eye Centre, Maharaja Ranjit Singh Marj, New Delhi.
Central
DELHI
110002
India |
| Phone |
9868001242 |
| Fax |
|
| Email |
meenakshithakar147@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Da Cruz Russell Mark |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 101, First floor, Department of Ophthalmology, Guru Nanak Eye Centre, Maharaja Ranjit Singh Marg, New Delhi.
Central
DELHI
110002
India |
| Phone |
9765323120 |
| Fax |
|
| Email |
rdacruz@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| No monetary support will be claimed. |
|
|
Primary Sponsor
|
| Name |
Dr Meenakshi Thakar |
| Address |
Director Professor, Guru Nanak Eye Centre, Maulana Azad Medical
College and associated hospitals, Maharaja Ranjit Singh Marg, New
Delhi - 110002 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Anju Rastogi |
Director Professor, Guru Nanak Eye Centre, Maulana Azad Medical
College and associated hospitals, Maharaja Ranjit Singh Marg, New
Delhi - 110002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Da Cruz Russell Mark |
Guru Nanak Eye Centre |
Guru Nanak Eye
centre, Maharaja Ranjit
Singh Marg, New Delhi
Central
DELHI |
9765323120
rdacruz@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H33||Retinal detachments and breaks, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Silicone oil filled eye (1000Cs) with settled retina |
|
| ExclusionCriteria |
| Details |
1. Recurrent retinal detachment.
2. Corneal scarring.
3. Dense cataract.
4. Non fixating patients.
5. Other retinal pathologies.
6. Hyperoleon. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean Difference in axial length measurement. |
1. Preoperative axial length
2. One month post operative axial length |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative refractive error in the subgroup requiring cataract surgery with Intra occular lens implantation. |
One month post operatively |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
23/04/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is aiming to compare the mean difference in axial length obtained by A scan biometry and Optical biometry in silicone oil filled eyes with a settled retina. In patients with a mild to moderate cataract the post operative refractive error will be estimated at one month post operative period. In Silicone Oil filled eyes there is an increase of axial length when measured using A-scan biometry. This is because the velocity of sound in silicone oil filled eyes is slower than in the vitreous humour. Therefore we need to apply a correction factor to adjust for the same. Axial length measurement using optical biometry in silicone oil filled eyes uses optical low coherence reflectometry principle and measures axial length along the visual axis of the eye. There is a controversy whether the conventional methods of accoustic biometry are as reliable as the Newer Optical Biomatry based methods in axial length evaluation in silicone oil filled eyes which this study is aiming to provide a better understanding of. |