| CTRI Number |
CTRI/2024/03/064082 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to see correction of already existing uneven eyesight in cataract patients by using various techniques during cataract surgery |
|
Scientific Title of Study
|
An observational and comparative study to evaluate correction of pre- existing astigmatism using paired opposite clear corneal incisions with and without limbal relaxing incisions in cataract patients undergoing topical phacoemulsification |
| 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 Priyanka Maurya |
| Designation |
MBBS, DNB Ophthalmology Resident |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD NO. 3 , First Floor, New BLDG, Srishti complex, Bhaktivedanta Swami Marg, Mira Road (East), Thane.
Thane
MAHARASHTRA
401107
India |
| Phone |
9664176359 |
| Fax |
|
| Email |
mepmaurya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suraj Bhagde |
| Designation |
MBBS, DNB Ophthalmology Consultant |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD NO. 3 , First Floor, New BLDG, Srishti complex, Bhaktivedanta Swami Marg, Mira Road (East), Thane.
Thane
MAHARASHTRA
401107
India |
| Phone |
|
| Fax |
|
| Email |
drsuraj.b@bhaktivedantahospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Maurya |
| Designation |
MBBS, DNB Ophthalmology Resident |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD NO. 3 , First Floor, New BLDG, Srishti complex, Bhaktivedanta Swami Marg, Mira Road (East), Thane.
Thane
MAHARASHTRA
401107
India |
| Phone |
9664176359 |
| Fax |
|
| Email |
mepmaurya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhaktivedanta Hospital and Research institute,Shrishti Complex,Bhaktivedanta Swami Marg, Mira Road(East),Thane-401107 |
|
|
Primary Sponsor
|
| Name |
Bhaktivedanta Hospital and Research institute |
| Address |
Shrishti Complex,Bhaktivedanta Swami Marg, Mira Road (East), Thane-401107 |
| 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 Priyanka Maurya |
Bhaktivedanta Hospital and Research Institute |
OPD NO. 3 , First Floor, New BLDG, Srishti complex, Bhaktivedanta Swami Marg, Mira Road (East), Thane.
Thane
MAHARASHTRA |
9664176359
mepmaurya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BhaktiVedanta Hospital Ethics Committee for Biomedical and Health Research |
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 |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients visiting OPD who have undergone topical clear corneal phacoemulsification cataract surgery.
2.All genders with age group between 30 yrs to 80 yrs. |
|
| ExclusionCriteria |
| Details |
1. Evidence of corneal trauma on biomicroscopic examination.
2. Evidence of acute or chronic corneal infections ,corneal ectasia.
3. Corneal dystrophies and Corneal degenerations.
4. Inflammatory conditions of the cornea or conjunctiva.
5. Patients with Pterygium.
6. Previous ocular surgeries.
7. Patients developing hypertrophic scars or nodules during wound healing.
8. Any intraoperative complications related to the main corneal incisions e.g. premature entry, wound burn, wound extension etc will be excluded from this study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To find out the impact of Paired Opposite Clear Corneal Incisions to correct preexisting astigmatism in cataract patients undergoing topical Phacoemulsification.
2.To find out the impact of Paired Opposite Clear Corneal Incisions combined with Limbal Relaxing Incisions to correct preexisting astigmatism in cataract patients undergoing topical Phacoemulsification.
3.To find out the stability of the correction achieved six weeks after the Phacoemulsification surgery. |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the amount of astigmatism corrected between the above two groups of patients with opposite clear corneal incisions.
2. To find out surgically induced astigmatism (SIA) in a third group with incision on the steeper axis and without opposite clear corneal incisions (Control Group).
3. To compare the astigmatism corrected by all the three groups of patients. |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
22/03/2024 |
| 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 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
The purpose of this observational and comparative case study is to evaluate correction in pre- existing astigmatism six weeks after Phacoemulsification surgery with paired opposite clear corneal incisions with or without limbal relaxing incision. This study will make us understand the effectiveness of opposite clear corneal incision with limbal relaxing incision (For astigmastism of more than 1.50D) or without limbal relaxing incisions(For astigmatism of less than 1.50D) in correcting pre existing astigmatism. The study will also compare the routine phacoemulsification with temporal clear corneal incision to calculate surgically induced astigmatism. The site and extent of limbal relaxing incision will be based on Modified Gills Nomogram. Patients who would have undergone topical Phacoemulsification surgery for cataract will be recruited. It will be a three group observational and comparative study including a control group. Keratometry will be done for the operated eye(s) free of charge to the patients. Comparative study will be done for various parameters as mentioned above and statistical analysis will be presented. STUDY PROCEDURES : This Observational comparative study will be conducted after approval from the Institutional Ethical Committee (IEC). Informed consent will be obtained from all the patients enrolled after phacoemulsification surgery. The study patients will be divided into 3 groups based on the astigmatism correcting incisions given during phacoemulsification :- Group 1 : In this group patients with astigmatism of less than or equal to 1.25 D will be recruited. These patients would have already been given Paired Opposite Clear Corneal incisions on the steeper axis (without Limbal Relaxing Incisions) during their Phacoemulsification cataract surgery. Group 2 : In this group patients with astigmatism of more than 1.25 D will be recruited. These patients would have already been given Paired Opposite Clear Corneal incisions on the steeper axis along with Limbal Relaxing Incisions (as per modified Gill’s nomogram) during their Phacoemulsification cataract surgery. Group 3 : Control Group - This group will include patients who would have undergone routine Phacoemulsification with clear corneal incisions on the steeper axis without any additional corneal incisions (to calculate surgically induced astigmatism). Patients will be recruited based on the criteria of each group. The patients will be recruited in the OPD during their routine post-operative visits to the operating surgeon. There will be intra group comparison of astigmatism as well as inter group comparison. All the patients from each group will undergo basic ophthalmic evaluation including but not limited to automated refraction, automated keratometry, uncorrected and best corrected visual acuity testing, measurement of intraocular pressure by non-contact tonometer, slit lamp examination of anterior segment and the retina after the surgery. |