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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  
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 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  
Status 
Not Applicable 
 
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. 
 
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