| CTRI Number |
CTRI/2024/10/075397 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the efficacy of various macular function tests in mature cataracts to B Scan Ultrasonography in pre-operative period at a tertiary eye care eye hospital in India |
|
Scientific Title of Study
|
Exploring the sensitivity and specificity of various macular function tests in mature cataracts and comparison to B Scan Ultrasonography at a tertiary care eye hospital in India |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G Anuradha |
| Designation |
Fellowship in cataract, IOL |
| Affiliation |
Sankara eye hospital |
| Address |
Room number 21,
General OPD,
Sankara eye hospital,
Varthur main road,
Kundalahalli gate,
Bangalore.
Bangalore
KARNATAKA
560037
India |
| Phone |
8008208553 |
| Fax |
|
| Email |
anuradhagali1412@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meena Gopinath Menon |
| Designation |
Consultant and head, Glaucoma |
| Affiliation |
Sankara eye hospital |
| Address |
Room no 26,Glaucoma opd ,
Sankara eye hospital,
Varthur main road,
Kundalahalli gate ,Bangalore.
Bangalore
KARNATAKA
560037
India |
| Phone |
9886283310 |
| Fax |
|
| Email |
meenagm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Singri Niharika prasad |
| Designation |
Consultant |
| Affiliation |
Sankara eye hospital |
| Address |
Room no 26 ,
Glaucoma opd,
Sankara eye hospital,
Varthur main road ,
Kundalahalli gate,
Bangalore.
Bangalore
KARNATAKA
560037
India |
| Phone |
8971846960 |
| Fax |
|
| Email |
singriniharika@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara eye hospital ,BANGALORE |
|
|
Primary Sponsor
|
| Name |
G Anuradha |
| Address |
Sankara eye hospital,
Varthur main road,
kundalahalli gate,
Bangalore -560037 |
| Type of Sponsor |
Other [SELF] |
|
|
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 G Anuradha |
Sankara eye hospital |
Room no 21,
General opd ,
Varthur main road,
kundalahalli gate,
Bangalore-560037
Bangalore
KARNATAKA |
8008208553
anuradhagali1412@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sankara Eye Hospital,Bangaloree |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H258||Other age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
41.00 Year(s) |
| Age To |
89.00 Year(s) |
| Gender |
Both |
| Details |
VISION WITH HAND MOVEMENTS, PERCEPTION OF LIGHT, PROJECTION OF RAYS(GRADE 4+,GRADE 5)sponcs grading |
|
| ExclusionCriteria |
| Details |
Immature cataract
Secondary cataracts(uveitic,post silicone oil)
Traumatic mature cataract
Eyes with sluggish pupil reaction or RAPD and No PL
Bilateral mature cataract |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Conventional macular function tests were altered when there was an evident posterior segment abnormality seen on B scan and post operative OCT |
Preoperative and Postoperative day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sensitivity & Speficity of each macular function tests |
Preoperatively & Post operative day 1 |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
28/10/2024 |
| 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="0"
Months="5"
Days="0" |
|
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
|
• Age-related cataracts are the leading cause of disease-related visual impairment globally, accounting for 94 million adults aged ≥50 years who experienced low vision or blindness in 2020. • Although cataract is easily treatable, a significant number of patients with a visually significant cataract (that is, a cataract with severe visual loss) remain undiagnosed in communities, especially in rural areas, due to the limited availability of, or accessibility to, cataract screening. • Prevalence of mature cataracts is 11.4% in India. • In our hospital incidence of mature cataracts is 12.54% (from March-May 2024) • The diagnosis and treatment outcome measurement in cases of mature cataracts is challenging. • Macular function tests are required for the evaluation of the macular function with opaque media in conditions including dense cataract and vitreous hemorrhage. • Conventional macular function tests were altered when there was an evident posterior segment abnormality seen on B Scan. So, in setup where B Scan ultrasonography is not available, the conventional macular function tests do help in cases of mature cataracts. OCULAR EXAMINATION: (pre operative ) 1.Visual acuity( PL, PR In all 4 quadrants ) 2.Slit lamp evaluation 3.Non contact tonometry 4.Dilated fundus examination 5.Following macular function tests were performed in dark room: Colour vision
Maddox rod test 1 and 2 Two point discrimination test Entoptic phenomenon
B Scan ultrasonography Post operative parameters (day 1): • 1.post operative visual acuity • 2.Dilated fundus examination • 3. OCT scan
Data is collected and sensitivity and specificity values of each macular function test is correlated with B Scan results and postoperative retina changes ,OCT scan and visual outcome.
|