| CTRI Number |
CTRI/2019/02/017524 [Registered on: 07/02/2019] Trial Registered Prospectively |
| Last Modified On: |
04/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Trial to treat seeing arc after cataract surgery |
|
Scientific Title of Study
|
A prospective trial to assess effect of modified phakic IOL implantation in ameliorating Negative Dysphotopsia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRoop |
| Designation |
Medical Director |
| Affiliation |
Centre for Sight |
| Address |
Centre for Sight
Roop Netralaya
E K Road
Meerut (UP)
INDIA
Meerut
UTTAR PRADESH
250001
India |
| Phone |
|
| Fax |
|
| Email |
roopfamous@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRoop |
| Designation |
Medical Director |
| Affiliation |
Centre for Sight |
| Address |
Centre for Sight
Roop Netralaya
E K Road
Meerut (UP)
INDIA
UTTAR PRADESH
250001
India |
| Phone |
|
| Fax |
|
| Email |
roopfamous@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRoop |
| Designation |
Medical Director |
| Affiliation |
Centre for Sight |
| Address |
Centre for Sight
Roop Netralaya
E K Road
Meerut (UP)
INDIA
UTTAR PRADESH
250001
India |
| Phone |
|
| Fax |
|
| Email |
roopfamous@gmail.com |
|
|
Source of Monetary or Material Support
|
| CFS Netralaya Pvt Ltd
Roop Netralaya
E K Road
Meerut |
|
|
Primary Sponsor
|
| Name |
Centre for Sight |
| Address |
Roop Netralaya
Meerut |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DrRoop |
Centre for sight at Roop Netralaya |
MD Room, 1st floor
Cataract Unit
Meerut
UTTAR PRADESH |
9897077115
roopfamous@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Centre for sight institutional medical ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H590||Disorders of the eye following cataract surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
modified phakic IOL |
Implanted in ciliary sulcus and results evaluated for 3 months |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients complaining of Negative Dysphotopsia after cataract surgery |
|
| ExclusionCriteria |
| Details |
Patients not willing to undergo second intervention |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Resolution of Negative Dysphotopsia |
Day 1, 7, 30, 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse event |
Day 0,1,7, 30, 90 |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/02/2019 |
| Date of Study Completion (India) |
02/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Negative dysphotopsia is defined as symptom of seeing crescentic shadow by the patients after cataract surgery. There is no very effective treatment available for this.Trial is proposed to be conducted in patients complaining of negative dysphotopsia after cataract surgery. A modified phakic lens will be implanted in ciliary sulcus and resolution of symptoms of negative dysphotopsia will be evaluated. Investigator believes that this could turn out to be an effective and simple solution of Negative Dysphotopsia. Results Out of 10 patients, 2 were in prophylactic group and 8 in therapeutic group. All patients were relieved of symptoms or did not experience negative dysphotopsia. ( had total relief while one had partial resolution of symptoms. No serious adverse event occured. One patient had transient IOP rise subsiding with medical treatment and one had slight change in refractive status. Conclusion The device is very safe and effective for treatment and prophylaxis of negative dysphotopsia. |