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CTRI Number  CTRI/2025/04/085622 [Registered on: 25/04/2025] Trial Registered Prospectively
Last Modified On: 24/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   To study the Pupil Constriction in Femto-Second Laser-Assisted Cataract Surgery (FLACS) vs Intravenous steroid, dexamethasone Injection before surgery.  
Scientific Title of Study   Comparative Analysis of Pupillary Constriction in Femto-Second Laser-Assisted Cataract Surgery (FLACS) vs Pre-Operative Intravenous Dexamethasone Injection: A Prospective Randomized Study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSri Ganesh 
Designation  Chief Medical Director 
Affiliation  Nethradhama Superspeciality Eye Hospital  
Address  Nethradhama Superspeciality Eye Hospital Department of Phacorefractive, Building no- 256/14, Kanakapura Road, 7th Block, Jayanagar, Bangalore, Karnataka - 560070

Bangalore
KARNATAKA
560070
India 
Phone  9845129740  
Fax    
Email  phacomaverick@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sushmitha Sri Ganesh 
Designation  Chief Research Officer 
Affiliation  Nethradhama Superspeciality Eye Hospital  
Address  Nethradhama Superspeciality Eye Hospital Department of Phacorefractive, Building no- 256/14, Kanakapura Road, 7th Block, Jayanagar, Bangalore, Karnataka - 560070

Bangalore
KARNATAKA
560070
India 
Phone  9448071800  
Fax    
Email  sush.samak@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sristi Shreya Malakar 
Designation  phaco refractive surgery fellows 
Affiliation  Nethradhama Superspeciality Eye Hospital  
Address  Nethradhama Superspeciality Eye Hospital Department of Phacorefractive, Building no- 256/14, Kanakapura Road, 7th Block, Jayanagar, Bangalore, Karnataka - 560070

Bangalore
KARNATAKA
560070
India 
Phone  8638125513  
Fax    
Email  srishtishreyamalakar25@gmail.com  
 
Source of Monetary or Material Support  
Nethradhama Superspeciality Eye Hospital Department of Phacorefractive, Building no- 256/14, Kanakapura Road, 7th Block, Jayanagar, Bangalore, Karnataka - 560070  
 
Primary Sponsor  
Name  Nethradhama Superspeciality Eye Hospital 
Address  Nethradhama Superspeciality Eye Hospital Department of Phacorefractive, Building no- 256/14, Kanakapura Road, 7th Block, Jayanagar, Bangalore, Karnataka - 560070  
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 Sristi Shreya Malakar  Nethradhama Superspeciality Eye Hospital   Department of Phacorefractive, Building no- 256/14, Kanakapura Road, 7th Block, Jayanagar, Bangalore, Karnataka - 560070 Bangalore KARNATAKA
Bangalore
KARNATAKA 		 8638125513

srishtishreyamalakar25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nethradhama Institutional ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H258||Other age-related cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparative Analysis of Pupillary Constriction in Femto-Second Laser-Assisted Cataract Surgery (FLACS) vs Pre-Operative Intravenous Dexamethasone Injection:  To compare the degree of pupillary constriction in patients undergoing Femto-Second Laser-Assisted Cataract Surgery with and without the administration of pre operative intravenous injection of dexamethasone. 
Intervention  Comparative Analysis of Pupillary Constriction in Femto-Second Laser-Assisted Cataract Surgery (FLACS)   To study the effect of pre operative intravenous dexamethasone on pupil size after laser pretreatment during Femto Second Laser-Assisted Cataract Surgery 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patient with cataract grade less than or equal to LOCS NO 1-4, CC 1-5, PSC 1-5.
Patients with cataract with a stable refractive error.
Patient with no significant coexisting ocular pathology.
Patients with cataract with no history of previous ocular surgeries.
Patients with cataract with a normal pupillary reaction and no history of known pupillary abnormalities.
Patient with cataract with well dilating pupil (greater than or equal to 8mm)
 
 
ExclusionCriteria 
Details  Known hypersensitivity or contraindication to corticosteroids, including dexamethasone.
Patients with uncontrolled systemic diseases.
Patients with ocular pathologies that could interfere with the study outcomes.
Patient with pupillary disorder or poorly dilating pupil (less than 8mm)
Pregnant or breastfeeding women.
Any condition that could result in difficulty in performing FLACS.
Patients planned for a combined procedure.
Patient with mature, intumescent cataract.
Patient with diabetes.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparative Analysis of Pupillary Constriction in Femto-Second Laser-Assisted Cataract Surgery (FLACS) vs Pre-Operative Intravenous Dexamethasone Injection:   post day 1,15 and 3 month 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the degree of pupillary constriction in patients undergoing Femto-Second Laser-Assisted Cataract Surgery with and without the administration of pre operative intravenous injection of dexamethasone.  post day 1,15 and 3 month 
 
Target Sample Size   Total Sample Size="280"
Sample Size from India="280" 
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)   06/04/2026 
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="1"
Months="0"
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  

Material and Method:

  • Study Type: Prospective, randomized, controlled clinical trial.
  • Place of Study: The study will be conducted at NETHRADHAMA super speciality eye hospital.
Duration of study: 12 months to allow for adequate data collection, including preoperative, intraoperative, and postoperative assessments

EQUIPMENTS TO BE USED-

1.     Snellen’s visual acuity charts

2.     Retinoscope (Heine)     

3.     Non Contact Tonometer (Topcon CT80 USA)

4.     Slit lamp (Topcon)

5.     4-mirror Gonioscope (volk)

6.     Direct & Indirect ophthalmoscope (Heine)

7.     Zeiss IOL master 700.

8.     ZEISS Quatera 700

9.    Lensar Laser System or Ziemer Z8

10.  Carl Zeiss Callisto

 

1. Randomization and Group Assignment:

  • Participants will be randomly assigned into two groups:
    • Group 1 (Intervention group): FLACS with preoperative IV dexamethasone injection 2ml (4mg/1ml) administered 30 minutes before surgery.
    • Group 2 (Control group): FLACS without the administration of IV dexamethasone injection.

 

 

2. Preoperative Assessments:

  • Complete Ocular Examination: Including best-corrected visual acuity (BCVA), slit-lamp bio microscopy, tonometry and dilated fundus examination.
  • Pupillary Reaction Assessment: Baseline pupillary size and reactivity to light will be recorded under standard illumination conditions (e.g., dim light and bright light) using Zeiss IOL master 700.
  • Pentacam: Preoperative corneal topography and pachymetry.
  • Biometry: Anterior segment biometry will be assessed to ensure eligibility for FLACS using IOL Master 700.

 

 

3. Intraoperative Procedures:

  • All patients will undergo FLACS with implantation of foldable IOL under topical anaesthesia.
  • All surgeries will be performed by single experienced surgeon using Lensar laser system or Zeimer Z8 and Zeiss Quatera 700.
  • All surgeries will be performed in Nethradhama super speciality hospital, Jayanagar. Banglore, India.

 

Routine preoperative mydriatic treatment consisting of tropicamide 0.8% and phenylephrine 5% eye drops (Itrop plus E/D), four times in the interval of 15 minutes 1 hour prior to surgery will be instilled. Group 1 patients will be given 2ml (4mg/1ml) intravenous injection of dexamethasone, 30 minutes prior to surgery. Surgery will be performed under topical anaesthesia, proparacaine hydrochloride 0.5% (E/D Paracain). After the eye is painted with 5% povidone iodine solution and sterile draping, patient is shifted under Lensar laser system or Zeimer Z8. The femtosecond laser interface will be docked, and vacuum suction will be applied. Standard laser parameters will be a 6 mm diameter laser lens fragmentation in six segments, followed by a 5 mm diameter capsulotomy will be made. A superior main incision of 2.8 mm width and two 1.1 mm paracenteses will be made with Femto Second Laser. Photographs will be taken in Lensar laser system/Zeimer Z8 to record the pupillary size before and after every steps performed during laser pretreatment.

Patient will be shifted to Zeiss Quatera 700 without any delay to continue the rest of the procedure. Photographs of pupil size will be taken with Callisto software (Zeis Meditec AG) at the beginning of procedure. Incisions will be opened with a blunt dissector. Viscoelastic will be injected into the anterior chamber. The laser-precut capsulotomy will be removed using Utrata forceps. The lens will be hydrodissected from the capsule. The nucleus will be removed using phacoemulsification. Cortex aspiration, hydro polishing of the posterior capsule, and removal of the viscoelastic substance will be performed using irrigation aspiration system followed by implantation of the foldable intraocular lens in the capsular bag. At the end of surgery, the paracenteses will be hydrated and anterior chamber will be formed. Pupillary size will be measured at the beginning and in the end of the procedure with Zeiss Callisto software.

 

4. Postoperative Assessments:

  • Immediate Postoperative Pupillary Assesment: Pupillary size will be assessed immediately postoperatively.
  • Inflammation and Intraocular Pressure: Anterior chamber inflammation will be checked in slit lamp (SUN Classification) and IOP measurements with NCT will be taken at follow-up visit of Day1, Day 14 and 3months)
  • Visual Acuity: Postoperative UCVA, and BCVA at 2 weeks, and 3 months post-surgery.
  • Complications: The presence of complications such as corneal edema, posterior capsular rupture, or other surgical issues will be recorded.

 

 

5. Outcome Measures:

  • Primary Outcome: The degree of pupillary constriction at various intraoperative stages.
    • Metric: Pupillary size at different stages (before and after femtosecond laser capsulotomy, during and after phacoemulsification).
  • Secondary Outcomes:
    • Postoperative Inflammation and IOP: Anterior chamber inflammation and IOP measurements.
    • Postoperative Complications: Incidence of complications such as corneal edema, pupillary abnormalities, or posterior capsular rupture.

 


 
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