| CTRI Number |
CTRI/2024/10/075304 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Competitive cross sectional study ] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing biometric factors in short eyes versus normal eyes
|
|
Scientific Title of Study
|
Comparison of Ocular biometric Parameters in Patients diagnosed with Nanophthalmos and in patients with Primary Angle Closure Disease |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharmila Rajendrababu |
| Designation |
Senior Glaucoma Consultant |
| Affiliation |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
| Address |
Glaucoma Services
Department Room No 300
3rd Floor OPD Block
No1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
|
| Email |
shamsreddy@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Venkatesh Prajna |
| Designation |
Chief |
| Affiliation |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
| Address |
Cornea Services
Department Room No 314
3rd Floor OPD Block
No1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
|
| Email |
prajna@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Venkatesh Prajna |
| Designation |
Chief |
| Affiliation |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
| Address |
Cornea Services
Department Room No 314
3rd Floor OPD Block
No1 Anna Nagar
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
|
| Email |
prajna@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital and Postgraduate Institute of Ophthalmology
Glaucoma Services
Department Room No 300
3rd Floor OPD Block
No1 Anna Nagar
Madurai 625020
TAMILNADU |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Sharmila Rajendrababu |
Aravind Eye Hospital |
Glaucoma Services
Department Room No 300
3rd Floor
OPD Block
No1 Anna Nagar
Madurai
TAMIL NADU |
914524356100
914522530984
shamsreddy@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aravind Eye Hospital, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H578||Other specified disorders of eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Patients diagnosed with Nanophthalmos |
One time intervention of 30 to 40 minutes duration |
| Comparator Agent |
Patients diagnosed with Primary Angle Closure Disease |
One time intervention of 30 to 40 minutes duration |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with nanophthalmos - study group
Diagnosed with primary angle closure disease -control group |
|
| ExclusionCriteria |
| Details |
1) Patients with corneal opacities
2) Patients who have undergone YAG peripheral iridotomy or cataract surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To analyze the ocular biometric parameters in patients with Nanophthalmos and in patients with Primary Angle Closure disease
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It may further support the continuation of understanding the risk factors with a large population
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/11/2024 |
| 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="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
Nanophthalmos is a condition
characterized by reduced size of the anterior and posterior segments of the
eye with abnormally thickened sclera
Diagnostically, axial length
(AL) below 20.5 mm and Retinochoroidal scleral thickness (RCS) > 1.7 mm
with no associated ocular malformations are grouped under this special
subtype of microphthalmos. The characteristic features include abnormally
thickened sclera, short AL, small corneal diameter, and crowding of the
anterior chamber secondary to a high lens to eye volume ratio. The
pathophysiological mechanisms in these two conditions are similar, however,
the role of thickened sclera in influencing the angle closure in
nanophthalmos is unexplored. Also, this study will help in understanding the
secondary angle closure component in short eyes.
Anterior segment optical
coherence tomography (AS-OCT), Ultrasound biomicroscopy (UBM), A scan and
B-mode USG can help assess the anterior and posterior segment biometric
parameters in these eyes.
|
|