| 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
|
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital, Pondicherry |
| Address |
Cuddalore main road
Thavalakuppam
Pondicherry - 605007 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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. |