| CTRI Number |
CTRI/2021/01/030467 [Registered on: 14/01/2021] Trial Registered Prospectively |
| Last Modified On: |
06/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the outcome and causes of an eye disease which results in increased pressure in eye |
|
Scientific Title of Study
|
Prognostic Ocular Characteristics and Short Term Visual Outcome of Patients with Neovascular Glaucoma Presenting at a Tertiary Eye Care Hospital in South India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AEH/PDY/EC/THESIS/56/2020 Version01 06/11/2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalini S Nair |
| Designation |
Primary DNB resident |
| Affiliation |
Aravind Eye Hospital Pondicherry |
| Address |
Room No 21
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8281912599 |
| Fax |
|
| Email |
shalini.s@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Upadhyaya |
| Designation |
Glaucoma Consultant |
| Affiliation |
Aravind Eye Hospital Pondicherry |
| Address |
Room No 21
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8489810704 |
| Fax |
|
| Email |
Swati.dr@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Upadhyaya |
| Designation |
Glaucoma Consultant |
| Affiliation |
Aravind Eye Hospital Pondicherry |
| Address |
Room No 21
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8489810704 |
| Fax |
|
| Email |
Swati.dr@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital Pondicherry |
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital Pondicherry |
| Address |
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry |
| 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 |
| Dr Shalini S Nair |
Aravind Eye Hospital Pondicherry |
Room No 21
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry
Pondicherry
PONDICHERRY |
8281912599
shalini.s@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aravind Eye Hospital Pondicherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H405||Glaucoma secondary to other eye disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Patients with Neovascular Glaucoma |
Observe the visual outcome and the prognostic factors for Neovascular Glaucoma |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed patients of NVG fitting into the diagnosis of NVG
Visual acuity of even no light light perception at presentation
Patients who have been treated earlier for primary cause like diabetic retinopathy(DR) central retinal vein occlusion (CRVO) or Ocular Ischaemic syndrome
|
|
| ExclusionCriteria |
| Details |
Patients with physical disability or mental or psychological ailments where ocular examination and follow ups would be difficult
Patients treated previously for NVG
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We expect that studying the clinical profile of NVG patients will help us in better understanding of NVG and understand the reasons for delayed presentation or poor follow up which can help in formulating follow up protocols for early detection and modify counselling techniques to improve follow ups and impart knowledge about the risk factors to the patients |
At 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
25/01/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet started the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim:
To
assess the clinical and demographic profile of patients presenting with
neovascular glaucoma at a tertiary eye care centre and to assess the prognostic
factors.
Objectives
Primary Objectives 1 To analyse the various
etiologies leading to NVG.
Secondary
objectives
1 To assess the risk factors and prognostic variables in the study population.
2 To assess the
relationship between the various patient characteristics in neovascular
glaucoma with the outcome
Expected
Outcome
We
expect that studying the clinical profile of NVG patients will help us in better
understanding of NVG and understand the reasons for delayed presentation or poor
follow up which can help in formulating follow up protocols for early
detection and modify counselling techniques to improve follow ups and impart
knowledge about the risk factors to the patients
|