| CTRI Number |
CTRI/2020/06/026093 [Registered on: 24/06/2020] Trial Registered Retrospectively |
| Last Modified On: |
18/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the safety parameters of two different modes of a corneal strengthening procedure in patients with Keratoconus. |
|
Scientific Title of Study
|
Comparison of efficacy and efficiency of continuous v/s pulsed modes of corneal collagen cross linking in keratoconus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kriti Mehrotra |
| Designation |
DNB resident |
| Affiliation |
Nethradhama Superspeciality Eye Hospital |
| Address |
256/14 Kanakapura main road
7th block, Jayanagar.
Bangalore
KARNATAKA
560082
India |
| Phone |
9513061660 |
| Fax |
|
| Email |
drkritimeh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namita C Anagol |
| Designation |
Consultant- Uvea |
| Affiliation |
Nethradhama Superspeciality Eye Hospital |
| Address |
256, 14 Kanakapura main road
7th block, Jayanagar.
Bangalore
KARNATAKA
560082
India |
| Phone |
9845370131 |
| Fax |
|
| Email |
namita589@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR Kriti Mehrotra |
| Designation |
DNB resident |
| Affiliation |
Nethradhama Superspeciality Eye Hospital |
| Address |
256, 14 Kanakapura main road
7th block, Jayanagar.
256, 14 kanakapura main road
7th block, jayanagar.
Bangalore
KARNATAKA
560082
India |
| Phone |
9513061660 |
| Fax |
|
| Email |
drkritimeh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nethradhama Superspeciality Eye Hospital
256/14, Kanakapura main road, Jayanagar 7th block, Bangalore 560082 |
|
|
Primary Sponsor
|
| Name |
Nethradhama Superspeciality Eye Hospital |
| Address |
256/14, Kanakapura main road,
Jayanagar 7th block
Bangalore 560082 |
| 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 Kriti Mehrotra |
Nethradhama Superspeciality eye hospital |
Cornea Department, SPC Block
256/14 Kanakapura main road
7th block Jayanagar.
Bangalore
KARNATAKA |
9513061660
drkritimeh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nethradhama Eye Hospital Institutional Ethics Committee |
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 |
| Comparator Agent |
CONTINUOUS MODE ACCELERATED CXL. |
In continuous light accelerated corneal collagen crosslinking (cl-ACXL), 30 mW/cm2 for 4 minutes of continuous UV-A light exposure, and energy dose of 7.2 J/cm2 is given. Total duration is 4 minutes. |
| Intervention |
PULSED MODE ACCELERATED CXL |
In pulsed light accelerated corneal collagen crosslinking (pl-ACXL) 8 minutes (1.5 sec. on/1.5 sec. off) of UV-A exposure at 30 mW/cm2 with an energy dose of 7.2 J/cm2 is given. Total duration is 8 minutes |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients giving written informed consent.
2. Patients within age group of 10-40yrs.
3. Patients with progressive keratoconus.
4. Patients with pre-operative corneal thickness measured with pachymetry of more than 400microns.
|
|
| ExclusionCriteria |
| Details |
1. corneal pachymetry less than 400 microns
2. decompensated cornea
3. corneal dystrophies
4. age> 40years and <10 years
5. pre-existing scar
6. severe dry eye
7. eyes with limbal stem cell deficiency.
8. corneal ectasia other thankeratoconus.
9. active ocular surface disorder.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy and safety of continuous and pulsed mode of corneal collagen cross linking for keratoconus patients. |
Relevant data will be collected preoperatively , at 1, 3, 6 months postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pre operative and post operative Uncorrected and best corrected visual acuity
2. Pre operative and post operative changes in corneal parameters
3. Pre operative and post operative changes in corneal thickness.
4. To assess the depth of stromal demarcation line following treatment
|
Relevant data will be collected preoperatively , at 1, 3, 6 months postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/01/2016 |
| Date of Study Completion (India) |
15/11/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
After topical anesthesia, the corneal epithelium is scraped. A drop of riboflavin 0.25% dextran solution is applied every 2 minutes for 10 minutes.For 25 eyes of 25 patients, exposure to UV light (365 nm, 30 mW/cm2) for 3 minutes using the KXL® system (Avedro, Inc.) was done. .For the other 25 eyes of 25 patients, exposure to UV light (365 nm, 30 mW/cm2) for 6minutes (1.5 sec on 1.5 sec off) using the KXL® system (Avedro, Inc.) was done. Later, patient follow up is done at 1, 3, 6months and results are compared using the following- 1. ORBSCAN- For evaluation of K max K steep K flat 2. PENTACAM - For evaluation of K max (ant and post) K steep (ant and post) K flat (ant and post) Corneal volume Pachymetry (apex and thinnest) 3. AS-OCT – For evaluation of depth of demarcation line. 4. CORVIS ST – to evaluate Pachymetry Deflection amplitude Applanation time 1 and 2 Applanation length 1 and 2 Applanation velocity 1 and 2 |