| CTRI Number |
CTRI/2024/10/076023 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
The effect of Carboxymethylcelluose on corneal thickness in glaucoma and non glaucoma patients |
|
Scientific Title of Study
|
The effect of 0.5 percentage Carboxymethylcellulose on corneal thickness in glaucoma and non glaucoma patients a stratified randomised control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Namitha N Rose |
| Designation |
PG Resident- M.S Opthalmology |
| Affiliation |
Believers Church Medical College |
| Address |
Believers Church Medical College,
St Thomas Nagar,
Kuttapuzha,
Thiruvalla
Pathanamthitta
KERALA
689103
India |
| Phone |
9497379979 |
| Fax |
|
| Email |
rosenamithan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Leena Mariyam Varghese |
| Designation |
Associate Professor , Ophthalmology department |
| Affiliation |
Believers Church Medical College |
| Address |
Believers Church Medical College,
St Thomas Nagar,
Kuttapuzha,
Thiruvalla
Pathanamthitta
KERALA
689103
India |
| Phone |
8762925383 |
| Fax |
|
| Email |
leenalincy.varghese@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Namitha N Rose |
| Designation |
PG Resident- M.S Opthalmology |
| Affiliation |
Believers Church Medical College |
| Address |
Believers Church Medical College,
St Thomas Nagar,
Kuttapuzha,
Thiruvalla
Pathanamthitta
KERALA
689103
India |
| Phone |
9497379979 |
| Fax |
|
| Email |
rosenamithan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Believers Church Medical College,
St Thomas Nagar,
Kuttapuzha,
Thiruvalla
Pathanamthitta
Kerala,
India
689103
|
|
|
Primary Sponsor
|
| Name |
Namitha N Rose |
| Address |
Believers Church Medical College,
St Thomas Nagar,
Kuttapuzha,
Thiruvalla
Pathanamthitta,
689103
|
| 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 Namitha N Rose |
Believers Church Medical College |
Ophthalmology OPD,
First Floor,
Believers Church Medical College Hospital,
Thiruvalla,
Pathanamthitta
Pathanamthitta
KERALA |
9497379979
rosenamithan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, BELEIVERS CHURCH MEDICAL COLLEGE |
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 |
0.5% CARBOXYMETHYLCELLULOSE EYE DROPS |
1 drop 3 times , per day, for one month in both eyes |
| Comparator Agent |
NO COMPARATOR AGENT USED-
|
No drug used. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Cases
1.Glaucoma patients using one or more of the same topical antiglaucoma medications for at least 3 months.
Controls
1.Non glaucoma subjects who are matched for age (± 5) and gender of the glaucoma patients |
|
| ExclusionCriteria |
| Details |
1.PATIENTS WITH ANY OTHER OCULAR OR CLINICALLY RELEVANT SYSTEMIC DISEASES (MEIBOMIAN GLAND DYSFUNCTION, SJOGREN SYNDROME, STEVEN JOHNSON SYNDROME).
2.HISTORY OF LUBRICANT INSTILLATION IN PAST 2 MONTHS
3.TREATMENT WITH ANY OTHER OPHTHALMIC DRUG EXCEPT TOPICAL ANTIGLAUCOMA DRUGS 4 WEEKS PRECEDING STUDY.
4.HISTORY OF OCULAR SURGERY IN PAST 6 MONTHS.
KNOWN HYPERSENSITIVITY TO CARBOXYMETHYLCELLULOSE. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• To compare the effect of carboxy methylcellulose (0.5%) in glaucoma patients and non-glaucoma patients in terms of
• central corneal thickness (CCT),
• mid peripheral corneal thickness (PCT)
• corneal epithelial thickness (CET)
• central epithelial thickness to central corneal thickness ratio
USING AS-OCT |
1 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To estimate the corneal thickness in glaucoma and non-glaucoma controls without lubricants. |
1 MONTH |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/11/2025 |
| 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="3"
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
|
Glaucoma is a leading cause of blindness prevailing in the world. In the United States, glaucoma is the second leading cause of blindness and it is the most frequent cause of blindness among African -Americans.. It was estimated that 12 million Indians would have been affected by 2020. Epidemiological studies on glaucoma involving adults age 40 years and above have estimated glaucoma prevalence between 2.7 and 4.3% among indians. The goal of treatment of glaucoma is to lower the rate of progression throughout a patient’s lifetime in order to maintain visual function and related quality of life. Elevation of Intraocular pressure remains as a treatable risk factor and is known to be associated with the progression of glaucoma A long-term therapy with topical intraocular pressure lowering agents is usually necessary to preserve the visual field and thus patients’ quality of life. Most of the patients with glaucoma require long term or lifelong use of eye drops which is associated with ocular surface diseases and thinning of cornea. Topical antiglaucoma medications depending on the class, could cause thinning, thickening or no change to the CCT. Ocular Lubricants when used is found to cause an increase in the central corneal thickness often after 2 weeks to one month of therapy in dry eye from the base line. This study is designed to investigate the effect of lubricants (0.5% carboxymethylcellulose -CMC- which is used as artificial tears in opd regularly and harmless with no side effects reposted as of now) on the central and peripheral corneal thickness and epithelial thickness in the glaucoma patients and non-glaucoma subjects.it is found to be beneficial it will become a boon the glaucoma patients with corneal thinning. - There are very few studies that have actually studied the CCT and mid PCT of glaucoma and non-glaucoma patients. Here we determine the CCT and mid PCT of glaucoma and non-glaucoma patients with and without carboxy methylcellulose. We determine the changes in the 3 zones of CET and CCT -namely central zone (0-2mm), paracentral zone (2-5 mm) and mid peripheral zone (5-7mm).
- None of studies have got any relevant information about a ratio between central epithelial to central corneal thickness. In this study, we try to assess if there is any difference in CET to CCT ratio among glaucoma and non-glaucoma patients with and without lubricants.
- If we can prove by the study that there is an increase in CCT and mid PCT with the use of lubricants in glaucoma patients, instilling lubricants along with antiglaucoma medications will improve the corneal thickness from the baseline and thus patients’ quality of life.
Hence the study becomes significant.
|