| 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
|
|
|
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
|
|
|
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 1â° of lens misalignment there
is a loss of 3% of astigmatic power correction. Misalignment by 30â° causes total loss of
astigmatic power of toric IOL and misalignment of greater than 30â° 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 0â°,
180Ⱐand 270Ⱐover 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. |