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CTRI Number  CTRI/2025/07/089935 [Registered on: 01/07/2025] Trial Registered Prospectively
Last Modified On: 28/06/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A videographic observational evaluation of eye pressure checking devices contact with the ocular surface 
Scientific Title of Study   A Videographic Observational Evaluation of Goldmann Applanation Tonometrys Contact with the Ocular Surface 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Annamalai O 
Designation  Medical Consultant 
Affiliation  Aravind Eye Hospital, Pondicherry 
Address  Department of Glaucoma Room no 21 Aravind Eye Hospital Cuddalore main road Thavalakuppam
Department of Glaucoma Room no 21 Aravind Eye Hospital Cuddalore main road Thavalakuppam
Pondicherry
PONDICHERRY
605007
India 
Phone  8098888247  
Fax    
Email  annamalai.o@aravind.org  
 
Details of Contact Person
Scientific Query
 
Name  Annamalai O 
Designation  Medical Consultant 
Affiliation  Aravind Eye Hospital, Pondicherry 
Address  Department of Glaucoma Room no 21 Aravind Eye Hospital Cuddalore main road Thavalakuppam
Department of Glaucoma Room no 21 Aravind Eye Hospital Cuddalore main road Thavalakuppam

PONDICHERRY
605007
India 
Phone  8098888247  
Fax    
Email  annamalai.o@aravind.org  
 
Details of Contact Person
Public Query
 
Name  Annamalai O 
Designation  Medical Consultant 
Affiliation  Aravind Eye Hospital, Pondicherry 
Address  Department of Glaucoma Room no 21 Aravind Eye Hospital Cuddalore main road Thavalakuppam
Department of Glaucoma Room no 21 Aravind Eye Hospital Cuddalore main road Thavalakuppam

PONDICHERRY
605007
India 
Phone  8098888247  
Fax    
Email  annamalai.o@aravind.org  
 
Source of Monetary or Material Support  
Aravind Eye Care System 
 
Primary Sponsor  
Name  Aravind Eye Hospital, Pondicherry 
Address  Cuddalore main road Thavalakuppam Pondicherry - 605007 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Annamalai O  Aravind Eye Hospital  Department of Glaucoma Room no 21 Aravind Eye Hospital Cuddalore main road Thavalakuppam
Pondicherry
PONDICHERRY 
8098888247

annamalai.o@aravind.org 
Dr Raji Koshy Daniel  Aravind Eye Hospital  Department of Glaucoma Room no 300 1, Annanagar, Madurai, Tamilnadu – 625020.
Madurai
TAMIL NADU 
9043525623

rajikoshy@aravind.org 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, Aravind Eye Hospital, Madurai  Approved 
Institutional Ethics Committee, Aravind Eye Hospital, Pondicherry   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 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Sequential patients presenting to the glaucoma clinics as new or follow-up patient in whom applanation tonometry would be performed

 
 
ExclusionCriteria 
Details  1. Patients with infectious eye disease (e.g., conjunctivitis, keratitis, or corneal ulcers), non-infectious conditions impacting the surface of the cornea or shape of the eye
2. Corneal opacities
3. Megalocornea
4. High myopes with greater than 6 D or presence of squint
5. Globe injury
6. Known HIV, hepatitis B, hepatitis C
7. Monocular or functionally monocular patients (phthisis, enucleation, retinal detachments)
8. Those who had any intraocular or lid surgery within the last six months
9. History of prion disease
10. Cognitive impairment
11. Pregnant women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Frequency of tonometer-mucous membrane touch and tonometer-eyelid touch   Single time point 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="2282"
Sample Size from India="2282" 
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)   10/07/2025 
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="4"
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 - NO
Brief Summary  


Glaucoma is the leading cause of irreversible blindness both in the United States and across the globe. The accurate measurement of intraocular pressure (IOP) is the foundation of both its diagnosis and management. High-quality tonometry is critical. The Goldmann applanation tonometer (GAT) replaced the Schiotz tonometer as the gold standard for tonometry in the 1950s. GAT requires the tonometer tip (3.06 mm in diameter) to contact the cornea (approximately 11.5 mm in diameter). There is no evidence in the literature that the GAT does touch the conjunctiva. 
Current disinfection guidelines classify GAT as semicritical, along with other instruments that contact the mucous membranes. Semicritical items require high-level disinfection using chemical disinfectants. Glutaraldehyde, hydrogen peroxide, ortho-phthalaldehyde, and peracetic acid with hydrogen peroxide are cleared by the Food and Drug Administration (FDA) and are dependable high-level disinfectants. The eye’s mucous membranes are the bulbar and palpebral conjunctiva and do not include the cornea; this is evident in the much higher infection rate in the conjunctiva versus the cornea. Due to the belief that GAT tips touch the mucous membrane (the conjunctiva), high-level disinfection is required. High-level disinfection for GAT can result in damage to instrumentation by dissolving the glue holding the tip together causing it to both swell and crack. This can harm patients and cause inaccurate intraocular pressure readings. To avoid the need for high-level disinfection, many healthcare systems have opted for disposable tonometer tips which have generated large amounts of plastic waste and imposed unstainable costs on healthcare systems. 
Currently, tonometer tips are classified as semicritical instruments and as such are in the same category as Cervical Diaphragm Fitting Rings, Cryosurgical Instrumentation, and Endocavity Probes by the CDC. Structural damage has been observed with a 1:10 sodium hypochlorite (5,000 ppm chlorine) and 3% hydrogen peroxide. Although these disinfectants and exposure times should kill pathogens that can infect the eyes, no studies directly support this.  The guidelines of the American Academy of Ophthalmology for preventing infections in ophthalmology focus on only one potential pathogen: HIV. Because a short and simple decontamination procedure is desirable in the clinical setting, swabbing the tonometer tip with a 70% isopropyl alcohol wipe is commonly performed. Preliminary reports suggest that wiping the tonometer tip with an alcohol swab and then allowing the alcohol to evaporate might be effective in eliminating HSV, HIV, and adenovirus. However, because these studies involved only a few replicates and were conducted in a controlled laboratory setting, further studies are needed before this technique can be recommended. In addition, two reports have found that disinfection of pneumotonometer tips between uses with a 70% isopropyl alcohol wipe contributed to outbreaks of epidemic keratoconjunctivitis caused by adenovirus type 8.
Therefore, GAT tips currently require high-level disinfection, a practice normally reserved for instrumentation contacting mucous membranes, which the tonometer does not. The diameter of the GAT tip is much smaller than the cornea (3.06 mm vs. 11.5 mm), and there is no evidence in the literature or by way of practical experience that the GAT tip touches the conjunctiva. However, all high-level disinfection protocols, which are indicated for semicritical instruments such as tonometers, cause tonometer tips to deteriorate. For instance, treating the tonometry tip with sodium hypochlorite for greater than 5 minutes or using heat or steam will irrevocably damage the tonometer tip. Additionally, it roughens the surface touching the cornea, potentially causing corneal abrasions and micro-abrasions.
We are therefore interested in providing videographic evidence in an observational study of what part of the eye is in actual contact with the tonometer tip as well as the frequency, if any, of any tonometer-mucous membrane touch and tonometer-eyelid touch. 
 
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