| CTRI Number |
CTRI/2025/03/083481 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of collagen crosslinking (bonding) using variable energy levels in progressive keratoconus (weak cornea) with thin cornea |
|
Scientific Title of Study
|
To study the clinical & biomechanical outcomes of collagen crosslinking using adjusted fluency in progressive keratoconus with thin cornea |
| 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. Pallavi Joshi |
| Designation |
Senior Consultant |
| Affiliation |
|
| Address |
Dept. of Cornea & Refractive Surgery, Sankara Eye Hospital
Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru
Bangalore
KARNATAKA
560037
India |
| Phone |
8147280162 |
| Fax |
|
| Email |
drpallavijoshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pallavi Joshi |
| Designation |
Senior Consultant |
| Affiliation |
|
| Address |
Dept. of Cornea & Refractive Surgery, Sankara Eye Hospital
Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru
Bangalore
KARNATAKA
560037
India |
| Phone |
8147280162 |
| Fax |
|
| Email |
drpallavijoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Pallavi Joshi |
| Designation |
Senior Consultant |
| Affiliation |
|
| Address |
Dept. of Cornea & Refractive Surgery, Sankara Eye Hospital
Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru
Bangalore
KARNATAKA
560037
India |
| Phone |
8147280162 |
| Fax |
|
| Email |
drpallavijoshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, Bengaluru, Karnataka |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru, Karnataka 560037 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nitish Kumar |
Sankara Eye Hospital, Bengaluru, Karnataka |
Room No. 28, Ground Floor, Dept. of Cornea & Refractive Surgery
Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru 560037
Bangalore
KARNATAKA |
9871328362
nitishkumar007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sankara Eye Hospital, Bengaluru, Karnataka |
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 |
Corneal collagen cross linking of eye |
Eligible patients (progressive keratoconus) will undergo collagen cross linking procedure with hypotonic riboflavin solution & UV-B with adjusted fluency (power) depending on the corneal thickness. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Keratoconus Patient from Age 10 to 30yrs
Primary Keratoconus
Thin corneas (Corneal pachymetry at thinnest point less than 400 microns)
|
|
| ExclusionCriteria |
| Details |
Not willing for C3R surgery
Endothelial disorder
Prior herpetic infection/Concurrent infection/Inflammation
Pre-existing ocular trauma
Severe corneal scarring or opacification
Pregnant and nursing mother
Previous intraocular and corneal surgery
Glaucoma
Hormonal Therapy
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare clinical outcomes using adjusted fluency vs standard hypo-osmolar Collagen Crosslinking in Progressive Keratoconus Ectasia stabilization by
1. Serial Tomography evaluation
2.Serial Corneal Biomechanical Profile evaluation using Corvis ST
|
Preop (baseline), Post op Day 5, Post op 1 Month,Post op 3 Month, Post op 6 Month, Post op 12 Month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Endothelial Status using Specular Microscopy
2. Higher Order Aberration using Tomography
3. Demarcation Line using ASOCT
4. Determine Quality of Life(QOL) Improvement using Indian Visual questionnaires
|
Preop (baseline), Post op Day 5, Post op 1 Month,Post op 3 Month, Post op 6 Month, Post op 12 Month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
07/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Study Title To study the clinical & biomechanical outcomes of collagen crosslinking using adjusted fluency in progressive keratoconus with thin cornea.
• Keratoconus is a progressive bilateral corneal ectatic dystrophy with irregular stromal thinning, resulting in a cone-like protrusion and significant vision loss. • In corneal collagen cross linking we use 1. Riboflavin 0.1 percent drops isotonic or hypotonic 2. Ultraviolet A 365 nm wavelength • The standard protocol uses 3 milliwatt per cm square intensity for 30 mins duration. • The accelerated protocol uses 9 milliwatt per cm square intensity for 10 mins duration. • The energy produced remains constant in both protocols at 5.4 Joule per cm square. The above mentioned conventional & hypotonic protocol does not include patients with corneal thickness of less than 400 microns i.e. thin cornea. Other protocols for thin cornea are not as effective as standard protocol & give less predictable results. We will be using the adjusted fluency protocol which is designed especially for patients with thin cornea. It achieves arrest of keratoconus & matches the international safety standards of the conventional protocols.
|