| CTRI Number |
CTRI/2024/03/064395 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
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Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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A clinical study to find if there any difference in the outcomes between the SINGLE VS TWO STEP t- PRK with respect to visual outcomes. And to study rate of corneal wound healing with different lubricating eye drops. |
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Scientific Title of Study
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Transepithelial photorefractive keratectomy : A randomized comparative study between two-step and one-step techniques of transepithelial PRK and the rate of wound healing with different lubricating eye drops. |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ganthi Chetana Lakshmi |
| Designation |
Post MBBS Primary DNB 1 st year |
| Affiliation |
Sankara eye hospital, Pedakakani, Guntur |
| Address |
Sankara eye hospital, Guntur- Vijayawada express highway,Pedakakani,Guntur, Andhra Pradesh, 522509
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9494069928 |
| Fax |
|
| Email |
chetanambbs14@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Sudhakar Potti |
| Designation |
Chief Medical Officer, Head of Department, Cornea |
| Affiliation |
Sankara eye hospital, Pedakakani, Guntur |
| Address |
Sankara Eye Hospital, Guntur- Vijayawada express highway, Pedakakani, Guntur, Andhra Pradesh, 522509
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9705190929 |
| Fax |
|
| Email |
sudhakar@sankaraeye.com |
|
Details of Contact Person
Public Query
|
| Name |
Ganthi Chetana Lakshmi |
| Designation |
Post MBBS Primary DNB 1 st year |
| Affiliation |
Sankara eye hospital, Pedakakani, Guntur |
| Address |
Sankara eye Hospital, Guntur- Vijayawada express highway, Pedakakani, Guntur, Andhra Pradesh, 522509
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9494069928 |
| Fax |
|
| Email |
chetanambbs14@gmail.com |
|
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Source of Monetary or Material Support
|
| Management of Sankara Eye Hospital, Guntur-Vijayawada express highway, Pedakakani, Guntur, Andhra Pradesh,522509 |
|
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Primary Sponsor
|
| Name |
Ganthi Chetana Lakshmi |
| Address |
Sankara Eye Hospital, Guntur- Vijayawada express highway, Pedakakani, Guntur, Andhra Pradesh , India,522509 |
| Type of Sponsor |
Other [Principal investigator] |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ganthi Chetana Lakshmi |
Sankara Eye Hospital |
Department of cornea, Roon number: 118 , Guntur- Vijayawada express highway, Pedakakani, Guntur, Andhra Pradesh , 522509
Guntur
ANDHRA PRADESH |
9494069928
chetanambbs14@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sankara eye hospital, Guntur |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1) Transepithelial Photorefractive Keratectomy. |
Each person recruited into the study will undergo the single step photorefractive keratectomy (stream light PRK) in the other eye for the treatment of myopic astigmatism.( Active control) |
| Intervention |
1)Transepithelial photorefractive keratectomy. |
Each person recruited into the study will undergo the two- step transepithelial phototherapeutic keratectomy- photorefractive keratectomy (PTK-PRK) in one eye for the treatment of myopic astigmatism. |
| Comparator Agent |
2) Lubricating eye drops |
The total participants will be divided into 3 groups and each group gets one of the three lubricating eye drops we are studying. Dosage : single drop in each eye( same type of eye drop in both eyes) administered 8 times a day for a duration of 1 month. This group will receive eye drops whose constituents are Sodium Hyaluronate 0.15% w/v, Polyethylene glycol 0.3% w/v, Propylene Glycol 0.3 % w/v, Hydroxypropyl guar |
| Intervention |
2) Lubricating eye drops |
The total participants will be divided into 3 groups and each group gets one of the three lubricating eye drops we are studying. Dosage : single drop in each eye( same type of eye drop in both eyes) administered 8 times a day for a duration of 1 month.This group will receive eye drops whose constituents are Polyethlene Glycol 0.4% w/v, Propylene Glycol 0.4% w/v, Sodium Perborate BP 0.028%, Hydroxypropyl guar gum. |
| Intervention |
2) Lubricating eye drops |
The total participants will be divided into 3 groups and each group gets one of the three lubricating eye drops we are studying. Dosage : single drop in each eye( same type of eye drop in both eyes) administered 8 times a day for a duration of 1 month. This group will receive eye drops whose constituent is plain Sodium Hyaluronate 0.1%. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1)People who have myopic astigmatism with a spherical error between -1 to -6 diopters and a cylindrical error between -0.5 to -4 diopters.
2)People who have a stable refractive error at least for the past 1 year.
3)People who can come for a followup duration of at least 1 month.
4)Normal corneal tomography.
5)Minimum pachymetry of 470 micrometers. |
|
| ExclusionCriteria |
| Details |
1)History of any previous corneal surgery.
2)Family history of keratoconus.
3)History of keloid tendency.
4)Pregnant,lactating women( upto 6 months of delivery).
5)If the person has keratitis or corneal scar.
6)Any corneal dystrophies.
7)Hyperopia. |
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Method of Generating Random Sequence
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Other |
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Method of Concealment
|
Other |
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Blinding/Masking
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Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
visual acuity
rate of corneal epithelial wound healing |
visual acuity on 1 and 3 months
rate of corneal epithelial wound healing on days 1,3,5 and 1 month |
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Secondary Outcome
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| Outcome |
TimePoints |
Pain & discomfort in eyes after surgery( t- PRK).
|
Pain & discomfort in eyes after surgery( t- PRK) on days 1, 3, 5 & at 1 month. |
|
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Target Sample Size
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Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Post Marketing Surveillance |
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Date of First Enrollment (India)
|
29/03/2024 |
| 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 |
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Estimated Duration of Trial
|
Years="1"
Months="6"
Days="28" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [chetanambbs14@gmail.com].
- For how long will this data be available start date provided 08-07-2025 and end date provided 09-02-2040?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
To find if there is any difference in the 1 month post -op visual outcome between the eyes which have undergone two step t-PRK vs single step t-PRK. Rate of corneal epithelial wound( created by the t-PRK) healing using 3 different lubricating eye drops with varying composition 1) PLAIN SODIUM HYALURONATE 0.1% 2) POLYETHYLENE GLYCOL 0.4% w/v, PROPYLENE GLYCOL 0.3% w/v, SODIUM PERBORATE 0.028% w/v, HYDROXYPROPYL GUAR GUM 3) SODIUM HYALURONATE 0.15% w/v, POLYETHYLENE GLYCOL 0.3% w/v, PROPYLENE GLYCOL 0.3% w/v, HYDROXYPROPYL GUAR Area will be calculated using an app called SketchAndCalc.
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