| CTRI Number |
CTRI/2025/07/090073 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
low astigmatism using opposite clear corneal incision |
|
Scientific Title of Study
|
Visual and refractive outcomes of management of low astigmatism using opposite clear corneal incision during cataract surgery |
| 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 Sri Ganesh |
| Designation |
Chief medical director |
| Affiliation |
Nethradhama superspeciality eye hospital |
| Address |
Head of Department of Phaco and Refractive services Nethradhama superspeciality eye hospital Kanakapura main road 7th block Jayanagar Bengaluru.
Bangalore
KARNATAKA
560070
India
Bangalore KARNATAKA 560070 India |
| Phone |
9845129740 |
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrSushmitha Sriganesh |
| Designation |
Research Director |
| Affiliation |
Nethradhama superspeciality eye hospital |
| Address |
Head of Department of Phaco and Refractive services Nethradhama superspeciality eye hospital Kanakapura main road 7th block Jayanagar Bengaluru.
Bangalore
KARNATAKA
560070
India
Bangalore KARNATAKA 560070 India |
| Phone |
9448071800 |
| Fax |
|
| Email |
sush.samak@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrSushmitha Sriganesh |
| Designation |
Research Director |
| Affiliation |
Nethradhama superspeciality eye hospital |
| Address |
Head of Department of Phaco and Refractive services Nethradhama superspeciality eye hospital Kanakapura main road 7th block Jayanagar Bengaluru.
Bangalore
KARNATAKA
560070
India
KARNATAKA 560070 India |
| Phone |
9448071800 |
| Fax |
|
| Email |
sush.samak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nethradhama superspeciality eye hospital, Kanakapura road, 7th block, Jayanagar, Bengaluru, Karnataka, India, 560070
|
|
|
Primary Sponsor
|
| Name |
Nethradhama Super Speciality Eye Hospital |
| Address |
256/14, Nethradhama Super Speciality Eye Hospital, Department of Phaco refractive surgery, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Shweta Samuel |
Nethradhama superspeciality eye hospital |
Department of Phaco and Refractive services, 256/14, Kanakapura main road, 7th block Jayanagar, Bengaluru. Bangalore KARNATAKA
Bangalore
KARNATAKA Bangalore KARNATAKA |
953539959
shwetasamuel28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nethradhama ethics committee |
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 |
| Comparator Agent |
OCCIs on horizontal white to white(WTW) measurements |
To determine the effect of OCCIs on horizontal white to white(WTW) measurements |
| Intervention |
To evaluate the efficacy, visual and refractive outcomes of opposite clear corneal
incisions |
To evaluate the efficacy, visual and refractive outcomes of opposite clear corneal
incisions combined with posterior chamber non toric intraocular lens implantation in correcting pre-existing astigmatism of less than 1D |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
82.00 Year(s) |
| Gender |
Both |
| Details |
Patients, both male and female, aged above 50 years and with nuclear sclerosis of grade 1-4
(LOCS III), cortical or posterior subcapsular cataract with pre existing regular against the rule
corneal astigmatism(steep axis 180°+/- 20°) between 0.5D to ID on partial coherence
interferometry (PCI |
|
| ExclusionCriteria |
| Details |
Irregular astigmatism on tomography.
Clinical or topographical keratoconus
Cormeal scars, dystrophies or peripheral degenerations
Previous ocular surgeries
Other ocular pathologies that could have an effect on the post operative visual functions
Any intraoperative or postoperative complication will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy, visual and refractive outcomes of opposite clear corneal
incisions combined with posterior chamber non toric intraocular lens implantation in
correcting pre-existing astigmatism of less than 1D
|
Patients will be evaluated postoperatively on day 1, day 15 and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of OCCIs on horizontal white to white(WTW) measurements |
Patients will be evaluated postoperatively on day 1, day 15 and 3 months |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
03/06/2026 |
| 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="0" 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
|
AIMS AND OBJECTIVES
1. To evaluate the efficacy, visual and refractive outcomes of opposite clear corneal
incisions combined with posterior chamber non toric intraocular lens implantation in
correcting pre-existing astigmatism of less than 1D
2. To determine the effect of OCCIs on horizontal white to white(WTW) measurements MATERIALS AND METHODS : A. Study design - Hospital based, prospective, interventional study. B. Study period – 6 months, June 2025 - November 2025 C. Study site - Nethradhama Super Speciality Hospital, Jayanagar, Bengaluru Sample size – 50 eyes
The sample size was calculated with G*Power software based on the formula an effective size
was 0.66 derived from the literature. Based on this, a minimum of 45 subjects/eyes were
required to achieve a statistical power of over 80% with significance level (a) of 5%. To account
for potential dropouts or data loss (~10%), a total of 50 eyes were considered for this study. Inclusion criteria :
Patients, both male and female, aged above 50 years and with nuclear sclerosis of grade 1-4
(LOCS III), cortical or posterior subcapsular cataract with pre existing regular against the rule
corneal astigmatism(steep axis 180°+/- 20°) between 0.5D to ID on partial coherence
interferometry (PCI) automated keratometry (IOLMaster 700, Carl Zeiss Meditec) and
Pentacam(Oculus) Exclusion criteria :
Irregular astigmatism on tomography.
Clinical or topographical keratoconus
Cormeal scars, dystrophies or peripheral degenerations
Previous ocular surgeries
Other ocular pathologies that could have an effect on the post operative visual functions
Any intraoperative or postoperative complication will be excluded from the study
Pre operative:
All patients satisfying the inclusion and exclusion criteria will undergo a complete ophthalmic
evaluation including uncorrected distance visual acuity (UDVA) and best corrected visual
acuity (BCVA), slit lamp examination, applanation tonometry and fundoscopy. Keratometry,
biometry with IOL Master 700(Carl Zeiss Meditec) and Schiempflug topography using
Pentacam(Oculus) will be done. Procedure :
All patients will undergo topical phacoemulsification with posterior chamber intraocular lens
implantation by one of two operating surgeons. The main port clear corneal incision will be made
on steep meridian which will be projected on the surgeon’s oculars using the Callisto Eye
System(Carl Zeiss Meditec) through data obtained from IOL Master 700(Carl Zeiss Meditec)
and from Pentacam(Oculus). Routine phacoemulsification and posterior chamber intraocular
lens implantation of a non toric IOL will be done. Following this a 2.8-mm, self-sealing clear
corneal incision will be made with a keratome 180° opposite to the main incision on the steep
meridian. Post operative:
Patients will be evaluated postoperatively on day 1, day 15 and 3 months for the following
tests.
UDVA (day 1, day 15 and 3months)
BCVA (day 1, day 15 and 3months)
Refraction (day 1, day 15 and 3months)
Keratometry and WTW using IOL Master 700(Carl Zeiss Meditec) and Pentacam(Oculus)
(day 15 and 3 months) General statistical methods and types of analyses:
All the statistical analysis will be performed using Python (version 3.13), and Jamovi (version
2.6.44). Variables will be presented as means ± SD, median with interquartile ranges(IQR), or
percentages, depending on the data distribution. Normality of data will be assessed using the
Kolmogorov-Smirnov (KS) test and Shapiro-Wilk test. For group comparisons, a paired sample
t-test/Wilcoxon Signed-Rank test will be used. Repeated measured ANOVA will be used to
compare differences across follow up periods. A two-tailed p-value of less than 0.05 will be
considered statistically significant. |