| CTRI Number |
CTRI/2025/10/095984 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of corneal biomechanical alterations and corneal ectasia |
|
Scientific Title of Study
|
Evaluation of corneal biomechanical alterations in keratoconus and pellucid marginal degeneration patients after RGP and ROSE K contact lens wear |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vandana Kamath |
| Designation |
Head of Department |
| Affiliation |
Sankara Eye Hospital |
| Address |
Department of optometry, Sankara College of Optometry Sankara Eye Hospital Varthur main road Kundalahalli gate, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9820541584 |
| Fax |
|
| Email |
vandu2388@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vandana Kamath |
| Designation |
Head of Department |
| Affiliation |
Sankara Eye Hospital |
| Address |
Department of Optometry, Sankara Eye Hospital Varthur main road Kundalahalli gate, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9820541584 |
| Fax |
|
| Email |
vandu2388@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vandana Kamath |
| Designation |
Head of Department |
| Affiliation |
Sankara Eye Hospital |
| Address |
Department of Optometry, Sankara Eye Hospital Varthur main road Kundalahalli gate, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9820541584 |
| Fax |
|
| Email |
vandu2388@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, Varthur main road, Bengaluru, Karnataka 560037 |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital, Varthur main road, Bangalore ,Karnataka 560037 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Namratha |
Sankara Eye Hospital |
Sankara Eye Hospital,Varthur main road,Bengaluru
Bangalore
KARNATAKA |
9820541584
vandu2388@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sankara Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H186||Keratoconus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
KCN and PMD patients
Eligible for RGP and Rose K CL |
|
| ExclusionCriteria |
| Details |
C3R surgery
Previous RGP and Rose K CL wear
Corneal scaring
Infectious or inflammatory ocular diseases
Corneal graft surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The corneal stiffness and deformation amplitude changes after 3 months and 6 months of Rose K contact lens wear in keratoconus and pellucid marginal degeneration patients. |
Baseline
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The difference in post lens wear changes in the corneal biomechanical properties between RGP and Rose K lenses. |
Baseline
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
25/10/2025 |
| 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="1"
Months="5"
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
|
To evaluate the corneal biomechanical alterations in patients with keratoconus and pellucid marginal degeneration following the use of RGP and Rose K contact lenses. Data comparision would be taken with the CORVIS ST parameters like CBI SP A1 DA RATIO IR
To monitor the changes in corneal stiffness and deformation amplitude after a 3 and 6 months of RGP and Rose K CL wear in both patient group.
To assess the difference in post lens wear changes in the corneal biomechanical properties between RGP and Rose K lenses.
To understand which lenses are the better option to maintain corneal integrity |