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CTRI Number  CTRI/2024/04/065712 [Registered on: 15/04/2024] Trial Registered Prospectively
Last Modified On: 12/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Toric intraocular lens for cataract surgery  
Scientific Title of Study   A Comparative Study on Visual Outcome and Rotational Stability After Different Toric Intraocular Lens Implantation During Cataract Surgery—A Randomized Controlled Trial 
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 SUCHETA PARIJA 
Designation  PROFESSOR AND HOD 
Affiliation  AIIMS BHUBANESWAR 
Address  DEPARTMENT OF OPHTHALMOLOGY, ROOM NO 164, 1ST FLOOR, AIIMS BHUBANESWAR, SIJUA, PATRAPADA, BHUBANESWAR

Khordha
ORISSA
751019
India 
Phone  9437044380  
Fax    
Email  suchetaparija@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr AAKANKSHA SHAW 
Designation  JUNIOR RESIDENT (ACADEMIC) 
Affiliation  AIIMS BHUBANESWAR 
Address  PG 3 HOSTEL, ROOM NO 310, AIIMS BHUBANESWAR RESIDENTIAL COMPLEX, SIJUA, PATRAPADA, BHUBANESWAR

Khordha
ORISSA
751019
India 
Phone  8820203024  
Fax    
Email  aakankshashaw8@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SUCHETA PARIJA 
Designation  PROFESSOR AND HOD 
Affiliation  AIIMS BHUBANESWAR 
Address  DEPARTMENT OF OPHTHALMOLOGY, ROOM NO 164, 1ST FLOOR AIIMS BHUBANESWAR, SIJUA, PATRAPADA, BHUBANESWAR

Khordha
ORISSA
751019
India 
Phone  9437044380  
Fax    
Email  suchetaparija@yahoo.com  
 
Source of Monetary or Material Support  
AIIMS BHUBANESWAR DEPARTMENT OF OPHTHALMOLOGY. 
 
Primary Sponsor  
Name  NOT APPLICABLE  
Address  NOT APPLICABLE 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SUCHETA PARIJA   AIIMS BHUBANESWAR   DEPARTMENT OF OPHTHALMOLOGY, ROOM NO 164 1ST FLOOR, AIIMS BHUBANESWAR SIJUA PATRAPADA BHUBANESWAR 751019
Khordha
ORISSA 
9437044380

suchetaparija@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H26||Other cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  HYDROPHILIC TORIC INTRAOCULAR LENS   HYDROPHILIC TORIC INTRAOCULAR LENS IMPLANTATION DURING CATARACT SURGERY AND COMPARE THE ASTIGMATISM AND VISUAL DYSFUNCTION CORRECTION WITH INTERVENTION  
Intervention  HYDROPHOBIC TORIC INTRAOCULAR LENS   HYDROPHOBIC TORIC INTRAOCULAR LENS IMPLANTATION DURING CATARACT SURGERY AND ASSESS HOW WELL THEY CORRECT ASTIGMATISM AND VISUAL DYSFUNCTION 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  PATIENTS WHO ARE
1. GREATER THAN 18 YEARS OF AGE PRESENTING WITH CATARACT,
2. REGULAR ASTIGMATISM OF GREATER THAN 1D CYLINDER,
3. WILLING TO IMPLANT TORIC INTRAOCULAR LENS.  
 
ExclusionCriteria 
Details  Patients presenting with
1. Astigmatism which is irregular in nature
2. Keratoconus and corneal pathologies
3. High myopia
4. Iris abnormality
5. Pupillary abnormality
6. Moderate to severe glaucoma
7. Macular pathology and retinal detachment
8. Amblyopia and strabismus
9. Advanced Diabetic Retinopathy
10. Optic atrophy
11. Antecedent ocular trauma
12. Antecedent ocular surgery
13. One eyed patient. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual acuity  Baseline, 1 month, 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate rotational stability of hydrophobic and hydrophilic toric IOLs at 1 month, 3 months and 6 months post
operative follow up. 
1 month, 3 months and 6 months post
operative follow up. 
Residual error with digital marking and slit lamp marking   Baseline, 1 month, 3 months and 6 months  
Quality of life assessment   Baseline, 6 months 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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   Phase 4 
Date of First Enrollment (India)   30/04/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Cataract is one of the leading causes of blindness which accounts for almost 51% of the world’s blindness. Pre-existing astigmatism of greater than 1.50 D is found in around 15-29% of cataract patients while 3-15% of cataract patients have pre-existing astigmatism of greater than 2 D. Notable astigmatism is often associated with poor visual acuity, escalating the dependence on prescription glasses and dwindling quality of vision by virtue of distortion and smearing of images. Hence reducing the astigmatism would lead to further improvement in the visual outcome after cataract surgery.For patients where both cataract and corneal astigmatism are present the lenticular component conferring to the astigmatism is eradicated by the surgery itself and the ultimate postoperative astigmatic error is governed by the corneal contribution. In such patients, if monocular intra ocular lens is implanted, the patient may require ancillary refractive surgeries like corneal incisions in steep meridian and femtosecond laser-associated astigmatic keratotomy. A number of these procedures are associated with complications such as delayed wound healing, lack of precision, and corneal epithelial defects to name a few. Therefore the preexisting astigmatism correction in cataract patients can be done by implanting toric intra ocular lens without need of any additional refractive surgeries.
Toric IOLs are made of acrylic hydrophobic or hydrophilic material, which have stable haptic design for rotational stability hence making it more predictable and more precise than corneal or limbal surgeries. It could also meet patients’ need of spectacle free vision. Factors determining better visual outcome with toric IOLs are accurate biometry values and rotational stabilitiy. It has been observed in few studies that, for around every 1⁰ of lens misalignment there is a loss of 3% of astigmatic power correction. Misalignment by 30⁰ causes total loss of astigmatic power of toric IOL and misalignment of greater than 30⁰ induces new astigmatism. These patients might require IOL realignment surgery. Toric IOLs shows greatest rotation in early post operative period usually within 1 hour of surgery and the rotation is minimal after 1 week post operatively. Factors associated with an increased likelihood of toric IOL rotation include inaccurate capsulorrhexis size and centration, long axial length, incomplete removal of viscosurgical devices and changes in intra ocular pressure. Various methods that can be used to evaluate the toric IOL alignment post operatively include slit lamp, retro illumination 14 | P a g e photographs, digital sequential photographs, software based analysis and optical coherence tomography.
The objectives of my study are
 Primary Objective:
 1.To compare and analyze the visual outcome among all cataract cases with astigmatism >1D cylinder undergoing different toric intraocular lens (IOLs) implantation during cataract surgery. 
Secondary Objectives: 
1.To evaluate rotational stability of different toric IOLs at 1 month, 3 months and 6 months post operative follow up. 
2. To compare the residual error with digital marking and slit lamp marking for toric IOL implantation.
 3. To assess the quality of life in all toric IOLs based on validated questionnaire
When patient presents to the OPD, BCVA, autorefractometry and keratometry will be recorded to look for any astigmatism. Further dilatation of eyes using eyedrop tropicamide and phenylephrine will be done and a detailed slit lamp examination will be performed to grade the cataract along with a detailed fundus examination. If significant grade of cataract is found and patient requires to undergo a cataract surgery then optical 21 | P a g e biometry will be done to determine the lens power and astigmatism present. Patient will then be admitted and planned for cataract surgery. Toric axis will be calculated using respective IOLs Toric calculator. Preoperatively on the day of surgery, patient will be seated with their eyes fixed at a distant light source (torch light) and the corneal light reflex is noted in both eyes. Lane’s preop bubble marker will be used to mark axes of 0⁰, 180⁰ and 270⁰ over the limbus. Intraoperatively, using Mendez ring the patient’s Toric axis is marked in supine position along with the incision site. Cataract surgery will be carried out and then the toric IOL will be implanted in the appropriate axis using markers provided in the toric IOL.
Patients will be reviewed post operatively after 1 month, 3 months and 6 months.
 
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