| CTRI Number |
CTRI/2020/03/024283 [Registered on: 26/03/2020] Trial Registered Prospectively |
| Last Modified On: |
19/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to assess vision after Deep Anterior Lamellar Keratoplasty - a type of corneal tranplant |
|
Scientific Title of Study
|
Evaluation of Quality of Vision after Deep Anteror Lamellar Keratoplasty |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Isha Gupta |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Departmant of Ophthalmology,
Guru Nanak Eye Centre,
Maulana Azad Medical College,
Delhi 110002
Central
DELHI
110002
India |
| Phone |
9555747495 |
| Fax |
|
| Email |
gupta.isha1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritu Arora |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Ophthalmology,
Guru Nanak Eye Centre,
Maulana Azad Medical College,
Delhi 110002
Central
DELHI
110002
India |
| Phone |
9968604331 |
| Fax |
|
| Email |
dr_rituarora@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ritu Arora |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Ophthalmology,
Guru Nanak Eye Centre,
Maulana Azad Medical College,
Delhi 110002
Central
DELHI
110002
India |
| Phone |
9968604331 |
| Fax |
|
| Email |
dr_rituarora@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology,
Guru Nanak Eye Centre,
Maulana Azad Medical College,
Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Department of Ophthalmology |
| Address |
Guru Nanak Eye Centre,
Maulana Azad Medical College,
Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Isha Gupta |
Guru Nanak Eye Centre |
Department of Ophthalmology,
Guru Nanak Eye Centre,
Maulana Azad Medical College,
Delhi-110002
Central
DELHI |
9555747495
gupta.isha1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H186||Keratoconus, (2) ICD-10 Condition: H185||Hereditary corneal dystrophies, (3) ICD-10 Condition: H17||Corneal scars and opacities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Deep Anterior Lamellar Keratoplasty |
Deep Anterior Lamellar Keratoplasty (a type of corneal transplant )in patients with corneal stromal diseases and a normal corneal endothelium |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Age > 7 years
2. Corneal stromal diseases with normal endothelium
3. Willing to follow up for atleast 4 months post surgery |
|
| ExclusionCriteria |
| Details |
1. Gross posterior segment pathology
2. Ocular comorbidity like amblyopia and strabismus
3. Pregnant and lactating females |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Best Spectacle Corrected Visual Acuity (BSCVA) |
4 months post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FACT contrast sensitivity |
4 months post surgery |
| Lenticule and residual host thickness |
4 months post surgery |
| Densitometry and Higher Order Aberrations from anterior and posterior corneal surface |
4 months post surgery |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
31/03/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Penetrating Keratoplasty (PKP) has been the treatment of choice for corneal diseases for the past 100 years. However during the last decade, because of advancement in surgical techniques, Deep Anterior Lamellar Keratoplasty (DALK), in which a maximal depth of corneal stroma is removed has gained popularity as an alternative to PK for the treatment of corneal diseases that do not affect the corneal endothelium and descemet membrane such as keratoconus, corneal stromal dystrophies and corneal stromal opacities. The main advantage of DALK is that it allows preservation of patient’s own endothelium, reducing the risk of immunological reactions, endothelial graft rejection and graft failure.
Multiple factors can limit post-DALK visual performance, including lower and higher order aberrations and light scatter caused by the surgical interface.However the relative contributions of these factors in visual performance after DALK are poorly understood.
The purpose of this study will be to evaluate the quality of vision after DALK in Indian eyes.These postoperative factors include those obtained by AS-OCT and corneal tomography, and anterior/posterior corneal HOAs. |