FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/066266 [Registered on: 24/04/2024] Trial Registered Prospectively
Last Modified On: 22/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study of secondary glaucomas in a tertiary eye care centre  
Scientific Title of Study   A study of clinical characteristics of secondary glaucomas in a tertiary eye care centre 
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 Anusha J 
Designation  M S , Fellow in Glaucoma 
Affiliation  Nethradhama Superspeciality Eye Hospital , Bangalore. 
Address  Department of Glaucoma , Nethradhama Superspeciality Eye Hospital,7 block Jayanagar , Bangalore.
Department of Glaucoma , Nethradhama Superspeciality Eye Hospital,7 block Jayanagar , Bangalore.
Bangalore
KARNATAKA
560070
India 
Phone  9611693611  
Fax    
Email  anushavinutha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shibi Dev B N 
Designation  Head of department , Glaucoma. 
Affiliation  Nethradhama Superspeciality Eye Hospital, Bangalore.  
Address  Department of Glaucoma , Nethradhama Superspeciality Eye Hospital,7 block Jayanagar , Bangalore.
Department of Glaucoma , Nethradhama Superspeciality Eye Hospital,7 block Jayanagar , Bangalore.
Bangalore
KARNATAKA
560070
India 
Phone  9986777892  
Fax    
Email  Drshibidev@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anusha J 
Designation  M S , Fellow in Glaucoma 
Affiliation  Nethradhama Superspeciality Eye Hospital,Bangalore. 
Address  Department of Glaucoma , Nethradhama Superspeciality Eye Hospital,7 block Jayanagar , Bangalore.
Department of Glaucoma , Nethradhama Superspeciality Eye Hospital,7 block Jayanagar , Bangalore.
Bangalore
KARNATAKA
560070
India 
Phone  9611693611  
Fax    
Email  anushavinutha@gmail.com  
 
Source of Monetary or Material Support  
Nethradhama Superspeciality Eye Hospital,7 th block ,Jayanagar, Bangalore 560070,Karnataka,India. 
 
Primary Sponsor  
Name  Dr Anusha J 
Address  Department of Glaucoma , Nethradhama Superspeciality Eye Hospital,7 block Jayanagar , Bangalore. 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anusha J  Nethradhama Superspeciality Eye Hospital,Bangalore.  Department of Glaucoma , Nethradhama Superspeciality Eye Hospital,7 block Jayanagar , Bangalore.
Bangalore
KARNATAKA 
9611693611

anushavinutha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nethradhama superspeciality eye hospital , Bangalore.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H404||Glaucoma secondary to eye inflammation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Secondary glaucomas 
 
ExclusionCriteria 
Details  Exclusion criteria
1)Not willing to participate .
2)Primary open –angle glaucoma (POAG) , primary angle closure glaucoma (PACG ), Congenital glaucoma.
3)Corneal opacity, degeneration,dystrophy or infections , which precludes IOP measurement by Goldmann applanation tonometer (GAT).

 
 
Method of Generating Random Sequence    
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study prevalence and etiology of secondary glaucomas, intraocular pressure by Goldmann applanation tonometry ,Gonioscopy,Visual field .

 
At the time of presentation to the out patient department of Glaucoma. 
 
Secondary Outcome  
Outcome  TimePoints 
To study the demography of secondary glaucomas.  At the time of presentation to the department. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   05/05/2024 
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="0"
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  

INTRODUCTION

Glaucoma is the second leading cause of blindness globally as well as in most regions , with the prevalence of over 76 million people affected ( 2010 -2020)  1

Glaucoma is defined as a multifactorial optic neuropathy, which is characterised by progressive damage of retinal ganglion cells and axons, and a thinning of nerve fibre layer and neuroretinal rim.When a related  or identifiable ophthalmic condition is known to be present , it is secondary glaucoma, i.e., glaucomas that occur as a side effect or secondary to another underlying medical condition or trauma.This differs from primary glaucoma where there is no identifiable cause for glaucoma to develop.

 

Previous studies have shown that secondary glaucoma occurred more in men than women in the age group of 51-60 years, commonly unilateral with intraocular pressure =/> 30 mmHg, most common lens induced glaucoma followed by steroid induced glaucoma 1.Other causes being neovascular glaucoma,traumatic , pseudoexfoliation, post vitrectomy.

Some studies also noted younger patients affected by secondary glaucoma and presentation with higher IOP, severe disc damage and visual field defects . 2

The management in secondary glaucoma differs from primary, as in secondary variety if the primary pathology is detected and treated at the earliest , glaucomatous damage can be prevented . 3

Need for the study

 

Six million people are affected by secondary glaucoma globally compared to 67 million of primary glaucoma.The prevalence varies from 6-22% globally and 0.7 -6 % in India with varied etiologies. 4

The various causes of secondary glaucoma include ocular and systemic conditions , lens pathologies,trauma, neovascularization,steroid –induced,inflammation , previous surgery, and others which poses formidable diagnostic and management challenge. 5

For each of these conditions,understanding the clinical profile of patients, mechanism of raise of intraocular pressure (IOP) helps us to focus on the underlying condition  and plan accordingly.

As secondary glaucoma is an important cause of visual morbidity , early diagnosis and appropriate treatment can help in prevention of irreversible visual loss.

 

Hence , this study is undertaken to investigate the characteristics of secondary glaucoma patients at a tertiary care hospital in Bangalore.

 

Objective of the study

To study the demography,underlying etiology,clinical characteristics and disease severity of secondary glaucomas.

 

MATERIALS AND METHODS

Source of data

Patients attending out patient department (OPD) of Nethradhadama superspeciality hospital , Glaucoma block, Bengaluru,Karnataka, India .

 

Inclusion criteria

1.     Patients of either gender aged < 70 years, U/L or B/L , IOP >21 mm Hg, with or without glaucomatous disc damage with ;

2.     Lens induced changes

3.     Pseudoexfoliation syndrome

4.     Steroid usage

5.     Ocular trauma

6.     Ocular inflammation

7.     Neovascularizartion of eye

8.     Retinal pathology / vitreo retinal surgery,previous ocular surgeries.

 

Exclusion criteria

1.     Not willing to participate

2.     Primary open –angle glaucoma (POAG) , primary angle closure glaucoma (PACG ), Congenital glaucoma

3.     Corneal opacity, degeneration,dystrophy or infections , which precludes IOP measurement by Goldmann applanation tonometer (GAT).

 

Study design: Cross-sectional descriptive study

 

Sample size: 60 consecutive patients

 

In India, the reported prevalence of secondary glaucoma ranged between 0.7 to 6.72%.    Considering   3.7%   prevalence with 5%  error   sample needed to conduct this study  is   55 cases.   60  cases  will be    selected.

 

 

Place of study: OPD, Glaucoma block , Nethradhama superspeciality hospital, Bengaluru, Karnataka.

 

Method of collection of data

 

Consecutive patients diagnosed as secondary glaucoma will be explained about the procedure and informed consent will be taken.

A detailed ophthalmic evaluation which includes the following:

 

1.     Visual acuity – both uncorrected and best corrected using Snellens chart and Jaegers chart for near vision.

2.     Refraction with streak retinoscope or auto refractometer.

3.     Detailed slit lamp examination of anterior segment.

4.     IOP measurement by GAT.

5.     Posterior segment evaluation by slit lamp fundus biomicroscopy using a +90D lens or Indirect ophthalmoscopy.

6.     Gonioscopy using 4 mirror gonio lens.

7.     Visual field examination by HFA 3 ( CZ Meditech ) and Optical coherence tomography (OCT) for optic nerve head and peripapillary retinal nerve fibre layer analysis .

 

Statistical Analysis

 

Categorical  data will be represented in the form of frequency and percentage.   Association between variables will be  assessed with Chi Square Test.  Quantitative data will be   represented as  Mean & Sd. Comparison will be done with Independent t test.A P value of <0.05 will be  considered statistically significant.Data was analyzed with IBM SPSS Version 28 for windows.

 

 

References

 

1.     Komaratih, E., Rindiastuti, Y., & Primitasari, Y. (2020). Profile of Secondary Glaucoma at a Tertiary Hospital in East Java. Folia Medica Indonesiana56(1), 56–59.

2.     Seth PK, Senthil S, Das AV, Garudadri C. Prevalence of glaucoma types, clinical profile and disease severity at presentation: Tertiary Institute based cross-sectional study from South India. Indian J Ophthalmol. 2023 Oct;71(10):3305-3312.

3.     Gadia R, Sihota R, Dada T, Gupta V. Current profile of secondary glaucomas. Indian J Ophthalmol. 2008 Jul-Aug;56(4):285-9.

4.     Partha Chakma , Debal Kisor Pal , Amar Kanti Chakma.A Clinical Study of Secondary Glaucoma with Special Reference to Its Proportion, Causes and Its Risk Factors in a Tertiary Care Hospital - A Cross Sectional Study . J Evid Based Med Healthc, 2021 Jan ;eISSN - 2349-2570

5.     Gurung J, Sitoula RP, Singh AK. Profile of Secondary Glaucoma in a Tertiary Eye Hospital of Eastern Nepal. Nepal J Ophthalmol. 2021 Jan;13(25):98-103. 

 
Close