| CTRI Number |
CTRI/2018/09/015651 [Registered on: 07/09/2018] Trial Registered Prospectively |
| Last Modified On: |
08/09/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Find out the Visual outcome of Phakic Intraocular Lens for the correction of Nearsightedness |
|
Scientific Title of Study
|
A Study on Efficacy and Visual outcome of Posterior chamber Phakic Intra-ocular lens in High Myopia |
| Trial Acronym |
Phakic IOL, Myopia |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr SIVAVIGANESH S |
| Designation |
M.S Ophthalmology Post Graduate |
| Affiliation |
Principle Investigator |
| Address |
Room No 43 Cornea Block GOVERNMENT OPHTHALMOLOGY HOSPITAL
REGIONAL INSTITUTE OF OPHTHALMOLOGY
RUKUMANI LAKSHMIPATHI ROAD
EGMORE
CHENNAI
Chennai
TAMIL NADU
600008
India |
| Phone |
9500768419 |
| Fax |
|
| Email |
dr.sivaviganesh@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Prof Dr ANANDABABU M |
| Designation |
Director - RIOGOH |
| Affiliation |
Professor- Ophthalmology |
| Address |
Room No 43 Cornea Block GOVERNMENT OPHTHALMOLOGY HOSPITAL
REGIONAL INSTITUTE OF OPHTHALMOLOGY
RUKUMANI LAKSHMIPATHI ROAD
EGMORE
Chennai
TAMIL NADU
600008
India |
| Phone |
9841183214 |
| Fax |
|
| Email |
anandcornea@yahoo.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Prof Dr ANANDABABU M |
| Designation |
Director -RIOGOH |
| Affiliation |
Professor- Ophthalmology |
| Address |
Room No.43 Cornea Block GOVERNMENT OPHTHALMOLOGY HOSPITAL
REGIONAL INSTITUTE OF OPHTHALMOLOGY
RUKUMANI LAKSHMIPATHI ROAD
EGMORE
Chennai
TAMIL NADU
600008
India |
| Phone |
9841183214 |
| Fax |
|
| Email |
anandcornea@yahoo.com |
|
|
Source of Monetary or Material Support
|
| APPASAMY ASSOCIATES, No 20 SBI OFFICERS COLONY, ARUMBAKKAM, CHENNAI-600106 |
| Regional Institute of Ophthalmology and Goverment Ophthalmic Hospital, Rukmani LakshmiPathi Road, Egmore, Chennai – 600008 |
|
|
Primary Sponsor
|
| Name |
DR SIVAVIGANESH |
| Address |
Room No.43,first floor, Cornea unit Block, Regional Institute of
Ophthalmology and Goverment Ophthalmic Hospital, Rukmani
LakshmiPathi Road, Egmore, Chennai - 600008
|
| Type of Sponsor |
Other [] |
|
|
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 SIVAVIGANESH S |
Regional Institute Of Ophthalmology and Government Ophthalmic Hospital |
Room No.43,first floor, Cornea unit Block, Regional Institute of Ophthalmology and Goverment Ophthalmic Hospital, Rukmani LakshmiPathi Road, Egmore, Chennai - 600008
Chennai
TAMIL NADU |
9500768419
dr.sivaviganesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Madras Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
High Myopic Patients, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Age >21 years
2. Stable refraction
3. Patients with myopia >-6.00D
4. Iridocorneal angle > 30 degree
5. Anterior chamber depth >2.7mm
6. Endothelial cell count > 2500 cells/sq.mm
7. Central corneal thickness >0.400 mm
|
|
| ExclusionCriteria |
| Details |
1. Age <18 years
2. Unstable refraction
3. Hyperopia
4. AC depth <2.7mm.
5. Iridocorneal angle <30 degrees
6. Endothelial cell count <2500 cells /sq mm
7. Central corneal thickness <0.400 mm.
8. Any Lens Changes
9.Any Retinal degeneration which cause Impaired vision
10.Any Inflammatory Pathologies of Eye
11.Any Previous Ocular Surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in Best corrected visual acuity
2.Anterior chamber depth
3.Iridocorneal angle
4.Endothelial count
6.Central corneal thickness
|
Post Op 1st Week 2nd Week 4th week 3rd Month and 6th Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Intra Ocular Pressure
2.RIL Vaulting between Natural Lens and Phakic IOL
3.Any Other Adverse Events |
Post Op 1st Week 2nd Week 4th week 3rd Month and 6th Month |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
17/09/2018 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Phakic IOL means that natural crystalline lens is retained and an intraocular lens (IOL) is placed into the eye. The phakic IOL implant functions as an internal contact lens and the view through the phakic IOL is natural and of a good quality. Phakic IOLs are used to treat high myopia or hyperopia with or without astigmatism who are not fit for LASIK or mild keratoconus Primary Objective of this study is Evaluate the Visual Outcome and Ensure the Safety of Posterior Chamber Refractive Implantable Lens (RIL) in High Myopic Patients In this Study all Patients will be Thoroughly Evaluated Pre-Operatively and Follow Up done at 1st week, 2nd Week, 4th Week , 3rd Month and 6th Month.The following Parameters will be assessed Visual Acuity, Anterior Chamber Depth, CCT, Endothelial Cell Count, IOP and Iridocorneal angle. |