| CTRI Number |
CTRI/2025/12/098479 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing laser-assisted cataract surgery with a new phacoemulsification method for people with posterior polar cataracts. |
|
Scientific Title of Study
|
Comparative evaluation of Femtosecond-Laser Assisted Cataract Surgery and Stratified Phacoemulsification in
management of Posterior Polar Cataract |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anika |
| Designation |
Postgraduate Resident |
| Affiliation |
Dr. Om Parkash Eye Institute |
| Address |
Second Floor, Room No. 05, Department of Cataract and Refractive Surgery, Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab
Second Floor, Room No. 05, Department of Cataract and Refractive Surgery, Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab
Amritsar
PUNJAB
143001
India |
| Phone |
09284279884 |
| Fax |
|
| Email |
chaudharyannie86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tushya Om Parkash |
| Designation |
Cataract and Refractive Surgery Consultant |
| Affiliation |
Dr. Om Parkash Eye Institute |
| Address |
Second Floor, Room No. 05, Department of Cataract and Refractive Surgery, Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab
Second Floor, Room No. 05, Department of Cataract and Refractive Surgery, Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab
Amritsar
PUNJAB
143001
India |
| Phone |
9980813156 |
| Fax |
|
| Email |
tushya@aol.in |
|
Details of Contact Person
Public Query
|
| Name |
Tushya Om Parkash |
| Designation |
Cataract and Refractive Surgery Consultant |
| Affiliation |
Dr. Om Parkash Eye Institute |
| Address |
Second Floor, Room No. 05, Department of Cataract and Refractive Surgery, Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab
Second Floor, Room No. 05, Department of Cataract and Refractive Surgery, Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab
PUNJAB
143001
India |
| Phone |
9980813156 |
| Fax |
|
| Email |
tushya@aol.in |
|
|
Source of Monetary or Material Support
|
| Dr. Om Parkash Eye Institute 117-A, The Mall, Amritsar, Punjab, India , 143001 |
|
|
Primary Sponsor
|
| Name |
Anika |
| Address |
Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab, India, 143001 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Anika |
Dr. Om Parkash Eye Institute |
Second Floor, Room No. 05, Department of Cataract and Refractive Surgery, Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab, India, 143001
Amritsar
PUNJAB |
9284279884
chaudharyannie86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Om Parkash Eye Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: H258||Other age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
comparison betwwen FLACS and stratified phacoemulsification results.
|
comparison of visual acuity , endothelial cell count , anterior segment and posterior segment findings mainly rate of posterior capsule rupture in patients undergoing FLACS and that of startified phacoemulsification |
| Intervention |
Femtosecond-Laser Assisted Cataract Surgery |
FLACS incorporates femtosecond laser technology to automate key steps like capsulotomy and lens fragmentation with exceptional precision. It offers increased reproducibility, reduced ultrasound energy usage, and minimized mechanical manipulation within the eye.
The laser creates a highly precise 5.0-mm anterior capsulotomy centered using real-time imaging. It then performs quadrant segmentation of the nucleus, and optional grid softening (250–500 µm) depending on cataract density. Pre-softening decreases phaco energy requirements and improves safety. A posterior offset of 1000 µm preserves a thick epinuclear cushion to protect the posterior capsule.
The capsulotomy disc is removed using the dimple-down technique, and gas bubbles generated during laser fragmentation are released by gently shifting the nucleus. Hydrodelineation is performed using short-pulse injections through a bent 26-gauge cannula to separate nucleus from epinucleus.
Phacoemulsification is carried out with low fluidic settings using a direct-chop technique without nuclear rotation, reducing zonular stress. Typical parameters include 5% longitudinal power, 50% torsional power, 450 mm Hg vacuum, 34 cc/min aspiration flow rate, and IOP of 44 mm Hg.
Residual epinucleus is removed gently with reduced power and vacuum settings, ensuring the posterior capsule remains protected. Finally, cortical material is aspirated, and an IOL is implanted similarly to standard phaco. |
| Intervention |
Stratified Phacoemulsification |
Stratified Phacoemulsification is an advanced modification of standard phacoemulsification that focuses on controlled, layered nucleus removal while preserving the epinuclear shell until the end of the procedure. This preserved epinucleus acts as a protective cushion for the posterior capsule and zonules, reducing intraoperative risks and maintaining chamber stability.
The procedure begins with a 2.8-mm temporal clear-corneal incision and a side-port incision to allow instrument access. A cohesive OVD is injected to maintain anterior chamber depth and protect ocular structures. A continuous curvilinear capsulorrhexis is created under viscoelastic cover to ensure a round, centered opening that supports stable IOL placement.
A Centurion phaco system with a balanced tip is used for nucleus removal, offering efficient emulsification with minimal turbulence. After creating a central trench, the stop-and-chop technique divides the nucleus into two halves. Stratified removal then begins: one quadrant is held with the phaco tip while the chopper is positioned superficially in the epinucleus. Pulling the nucleus centrally while the chopper anchors the epinucleus separates the dense nucleus from the softer shell. Each nuclear segment is emulsified individually, while the epinucleus remains intact.
This process is repeated until all nuclear fragments are removed, leaving a thin epinuclear bowl. The epinucleus is aspirated gently under low IOP to avoid stressing the posterior capsule. After cortical cleanup, viscoelastic is reintroduced, a single-piece foldable IOL is implanted in the capsular bag, and all OVD is removed. Hydration of the incisions ensures watertight closure. Stratified phacoemulsification thus provides excellent safety, especially in dense cataracts, by maintaining a natural protective shell until late in surgery. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than 40 years.
2.Diagnosis of posterior polar cataract based on slit lamp evaluation and
anterior segment optical coherence tomography (AS-OCT) with nuclear
sclerosis.
3.Clear cornea
4.Written informed consent obtained for participation in the study. |
|
| ExclusionCriteria |
| Details |
1.Pupil size less than 5.5mm.
2.History of previous ocular surgery.
3.Endothelial cell count less than 1500 cells per mm.
4.Presence of any other ocular pathology.
5.Unwillingness or inability to provide informed consent and comply with
follow up schedule. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To determine and compare the incidence of posterior capsular rupture in both
Femtosecond-Laser Assisted Cataract Surgery (FLACS) and stratified
phacoemulsification patients and its impact on Intraocular Lens (IOL)
placement.
2.To assess intraoperative timing of Posterior Capsule Rupture (PCR) and
management strategies used.
3.To assess and compare the postoperative Best Corrected Visual Acuity
(BCVA) using LogMAR chart in both groups.
4.To evaluate postoperative complications in both groups.
5. To evaluate and compare the Loss of endothelial cell density (ECD). |
Follow-up will be done on Post-Op Day (POD) 1, after 1 week, 1 month and 3
months. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/12/2025 |
| 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
|
This randomized, prospective study seeks to compare Femtosecond-Laser Assisted
Cataract Surgery (FLACS) and stratified phacoemulsification in managing posterior
polar cataracts. By evaluating the incidence and management of posterior capsular
rupture, postoperative visual outcomes, complication rates, and endothelial cell loss,
the study aims to determine which technique offers greater safety and efficacy. The
results are expected to guide surgeons in selecting the most appropriate approach
for this high-risk cataract type and improve patient care outcomes. |