| CTRI Number |
CTRI/2024/04/065023 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of corneal wound characteristics and post-operative visual outcomes with two different incision sizes - 2.2mm vs 2.8mm during IOL implantation in phacoemulsification surgery in patients with age related cataract |
|
Scientific Title of Study
|
Comparison of 2.2 mm vs 2.8 mm clear corneal wound characteristics following wound assisted IOL injection |
| 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. Rajeshwari Kapoor |
| Designation |
DNB Resident |
| Affiliation |
Aravind Eye Hospital |
| Address |
Aravind Eye Hospital,
Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee
Chennai TAMIL NADU 600077 India |
| Phone |
9811616222 |
| Fax |
|
| Email |
rajeshwari.kapoor@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Seema Ramakrishnan |
| Designation |
Consultant, Cornea and Refractory Surgery Services |
| Affiliation |
Aravind Eye Hospital |
| Address |
105, Department of Cornea and Refractory Surgery Services
Aravind Eye Hospital,
Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee
Chennai TAMIL NADU 600077 India |
| Phone |
9884848224 |
| Fax |
|
| Email |
seemadr@aravind.org |
|
Details of Contact Person Public Query
|
| Name |
Dr. Seema Ramakrishnan |
| Designation |
Consultant, Cornea and Refractory Surgery Services |
| Affiliation |
Aravind Eye Hospital |
| Address |
105, Department of Cornea and Refractory Surgery Services
Aravind Eye Hospital,
Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee
Chennai TAMIL NADU 600077 India |
| Phone |
9884848224 |
| Fax |
|
| Email |
seemadr@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital,
Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee
Chennai, 600077
Tamil Nadu
India |
|
|
Primary Sponsor
|
| Name |
Rajeshwari Kapoor |
| Address |
Aravind Eye Hospital
Poonamallee High Road
Noombal
Chennai Tamil Nadu 600077 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Rajeshwari Kapoor |
Aravind Eye Hospital |
105, Department of Cornea and Refractory Surgery Services
Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee Chennai TAMIL NADU |
9811616222
rajeshwari.kapoor@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aravind Eye Hospital, Chennai (IEC-AEH CHN) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with age related cataract
Age 45 years and above
Patients undergoing phacoemulsification surgery
Phacoemulsification surgery done through a temporal incision
Patients with intraocular lens power ranging from plus 18D to plus 25D
Willing to participate in the study
Willing for follow up visits
|
|
| ExclusionCriteria |
| Details |
Pterygium Grade II and Grade III
Previous ocular surgery
Pre existing irregular astigmatism
Corneal opacity
Patients with Fuchs endothelial corneal dystrophy or significant guttata seen preoperatively
Patients with arcus senilis
Intraoperative obvious wound extension, tear or Descemet membrane detachment noted before IOL implantation
Frank clinically significant DMD happening at the step of wound hydration, when it was not noticed prior to that point
Intraoperative posterior capsular rent and zonular dehiscence
Intraoperative use of iris hooks |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of incidence of wound site Descemet membrane detachment in the three groups |
Intra operatively
Post operative day 1
Post operative day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of IOL safety |
Intra operatively |
| Comparison of wound size extension |
Intra operatively |
| Comparison of keratometry and surgically induced astigmatism |
Post operative day 21
Post operative day 90 |
|
|
Target Sample Size
|
Total Sample Size="99" Sample Size from India="99"
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)
|
08/04/2024 |
| 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 |
|
Estimated Duration of Trial
|
Years="1" Months="6" 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
|
This study aims to evaluate wound extension, IOL safety, Descemet membrane detachment and surgically induced astigmatism in phacoemulsification surgery using the wound assisted technique of IOL implantation and to study their relationship with incision size. This will be a prospective, observational study conducted at Aravind Eye Hospital, Chennai. All surgeries will be performed by 4 experienced surgeons, using the Centurion Phacoemulsification system under topical or sub-Tenon’s anaesthesia. Surgery will be performed via standard clear corneal incisions of either 2.2mm or 2.8mm size depending on the intraocular lens that the patient has chosen. Once the cataract has been removed from the eye, the incision size will be measured by a device called incision gauge. Following this, the IOL will be injected through this incision inside the eye. The surgeon will once again measure the incision size after this step. The surgery would be concluded as usual. In the event of detecting any nicks, scratches or breaks of the intraocular lens (IOL) during its insertion, their presence will be duly observed and documented by the surgeon. ASOCT will be done for all patients to analyse wound size, wound gape and non-apposition of the incision and detect the presence of Descemet membrane detachment on post-operative day 1 and post-operative day 21. Biometry will be done for all participants pre-operatively, on post-operative day 21 and on post-operative day 90 to check for keratometry and surgically induced astigmatism. |