| CTRI Number |
CTRI/2018/01/011332 [Registered on: 15/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
13/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two intraocular lenses for correction of cylinder power |
|
Scientific Title of Study
|
Comparative evaluation of two different Toric Intraocular Lenses for correcting astigmatism in patients undergoing phacoemulsification |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GMC/TA-I/(19-D)/2014/43647 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheetal Aatrai |
| Designation |
MS Ophthalmology |
| Affiliation |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Ophthalmology, level 3
Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
08872971715 |
| Fax |
|
| Email |
ssheital@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh Kumar Bansal |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Ophthalmology
Government Medical College and Hospital, Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121589 |
| Fax |
|
| Email |
bansalrk@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rakesh Kumar Bansal |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Ophthalmology
Government Medical College and Hospital, Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121589 |
| Fax |
|
| Email |
bansalrk@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Government Medical College and Hospital Sector 32 160030 Chandigarh |
| 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 |
| Rakesh Kumar Bansal |
Government Medical College and Hospital |
Department of Ophthalmology,level 3 Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH |
9646121589
bansalrk@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee Government Medical College and Hospital Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1 |
Patients implanted with plate haptic toric IOL (AT Torbi, Zeiss) |
| Comparator Agent |
Group 2 |
Patients implanted with loop haptic toric IOL (Acrysof) |
| Intervention |
Toric IOL implantation |
The patients were implanted either plate haptic toric IOL (AT Torbi, Zeiss)(Group 1) or loop haptic toric IOL (Acrysof)(Group 2) |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with cataract associated with preoperative regular corneal astigmatism between 1-5 D |
|
| ExclusionCriteria |
| Details |
Patients with irregular astigmatism, corneal dystrophy, tear-film instability, pupillary abnormalities, glaucoma, uveitis, retinal diseases, optic atrophy, or neuro-ophthalmic disease were excluded. Patients developing intra-operative complications like posterior capsule rent or extension of capsulorhexis or zonular dialysis were also excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Uncorrected visual acuity, Best corrected visual acuity (BCVA), Keratometry, IOL position after full mydriasis by masked observer on slit lamp biomicroscope |
Postoperatively at 1 week, 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A note of complications such as persistent corneal edema, pupillary block, retinal detachment, endophthalmitis and/ or need for neodymium:YAG capsulotomy |
Postoperatively at 1 week, 1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2015 |
| Date of Study Completion (India) |
06/07/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose: To compare the efficacy of AT-TORBI
plate haptic toric intraocular lens (IOL) (Carl Zeiss Meditec AG, Jena,
Germany) and AcrySof loop haptic toric
intraocular lens (IOL) (Alcon Laboratories, Inc., Fort Worth, TX) for
correcting pre-existing astigmatism of ≥1dioptres (D) in patients undergoing
phacoemulsification and to compare the rotational stability of these two toric
IOLs.
Design:
Prospective randomized controlled
trial.
Methods :
Forty two eyes of 42 cataract
patients with preexisting astigmatism of 1D or more were randomized to receive
plate haptic toric (AT TORBI) or loop haptic toric (AcrySof) IOL, with 21 in
each group. Post-operative evaluation was done at day 1, 1 week, 1 month and 3
months. Uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA)
and IOL position were noted in both the groups.
Results :
At three months post operatively, the mean log MAR UCVA was 0.2 in both the
groups (p =0.7), the mean residual
cylindrical refractive error in plate haptic toric group was 0.40 ± 0.31 D and
in loop haptic group was 0.45 ±
0.33 D (p = 0.64). The mean IOL
rotation at 3 months follow up in plate haptic group was found to be 3.52 ±
3.84° and in loop haptic group was 2.05 ± 2.56° (p = 0.25).
Conclusion:
Both types of toric IOLs were
equally efficacious for correcting uncorrected visual acuity and pre-existing
astigmatism between 1-5 D. Both of them were rotationally stable at 3 months
follow up. |