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CTRI Number  CTRI/2024/02/062689 [Registered on: 15/02/2024] Trial Registered Prospectively
Last Modified On: 08/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Assessment of Pattern of Adherence to Eyedrops for Eye Pressure Disease among Glaucoma (increased eye pressure) Patients and the associated various patient related factors 
Scientific Title of Study   Assessment of Adherence to Topical Anti-glaucoma Medications among Glaucoma Patients- A Cross-sectional Study 
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 Rucha Arvind Godbole 
Designation  Senior DNB Resident 
Affiliation  Aravind Eye Hospital Pondicherry 
Address  Aravind Eye Hospital, Cuddalore Main road, Thavalakuppam, Pondicherry

Pondicherry
PONDICHERRY
605007
India 
Phone  7769996592  
Fax    
Email  rucha.arvind@aravind.org  
 
Details of Contact Person
Scientific Query  
Name  Dr. S. Kavitha 
Designation  Head of Department, Glaucoma Services 
Affiliation  Aravind Eye Hospital Pondicherry 
Address  Aravind Eye Hospital, Cuddalore Main road, Thavalakuppam, Pondicherry

Pondicherry
PONDICHERRY
605007
India 
Phone  9894611575  
Fax    
Email  kavitha@aravind.org  
 
Details of Contact Person
Public Query  
Name  Dr Rucha Arvind Godbole 
Designation  Senior DNB Resident 
Affiliation  Aravind Eye Hospital Pondicherry 
Address  Aravind Eye Hospital, Cuddalore Main road, Thavalakuppam, Pondicherry

Pondicherry
PONDICHERRY
605007
India 
Phone  7769996592  
Fax    
Email  rucha.arvind@aravind.org  
 
Source of Monetary or Material Support  
Aravind Eye Hospital Pondicherry 
 
Primary Sponsor  
Name  Dr Rucha Arvind Godbole 
Address  Aravind Eye Hospital, Cuddalore Main road, Thavalakuppam, Pondicherry 
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 Rucha Arvind Godbole  Glaucoma Services, Aravind Eye Hospital  Cuddalore Main road, Thavalakuppam
Pondicherry
PONDICHERRY 		 7769996592

rucha.arvind@aravind.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Aravind Eye Hospital, Pondicherry(IEC-AEH-P)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H401||Open-angle glaucoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  Observational study 
Intervention  NIL  Observational study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients diagnosed with any type of glaucoma who are on medical therapy for a minimum period of one year 
 
ExclusionCriteria 
Details  Patients with other associated ocular pathologies except cataract, that would affect visual prognosis.
Patients who are mentally challenged.
Patients with any previous intraocular surgeries or lasers done within 6 months prior to recruitment date. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage of patients who are not adherent to topical anti-glaucoma medications  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Association between various patient related factors including demographic & socioeconomic factors & adherence to anti-glaucoma medications  1 year 
 
Target Sample Size   Total Sample Size="374"
Sample Size from India="374" 
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)   01/03/2024 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rucha.arvind@aravind.org].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Research Questions:
1. What is the proportion of patients who are non-adherent to topical anti-glaucoma medications?
2. What are the various factors influencing adherence to anti-glaucoma medication(s) in patients presenting to tertiary eye hospital?
3. What are the effects/influence of the duration of disease and the type of glaucoma on pattern of adherence to anti-glaucoma medication(s)?
4. What is the impact of drug induced/glaucoma related symptoms on adherence?

Aim: To study the pattern of adherence to anti-glaucoma medication(s) and the associated factors in patients presenting to glaucoma clinic in a tertiary eye care hospital.

Primary Objective: To assess the proportion of patients who are not adherent to topical anti-glaucoma medications.

Secondary Objectives:
1. To assess the association between various patient related factors including demographic and socioeconomic factors and adherence to anti-glaucoma medications.
2. To assess the knowledge levels about glaucoma in the study participants and its impact on adherence to anti-glaucoma medications.
 
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