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To evaluate whether the laser made circular capsular flap technique is safe and efficacious in laser assisted cataract surgery for hard cataracts

To evaluate the safety and efficacy of Femto capsulotomy flap technique in Femtosecond Laser assisted cataract surgery for Dense cataracts

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/022660
Enrollment
50
Registered
2020-01-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H251- Age-related nuclear cataract

Interventions

Intervention1: Femto capsulotomy flap in FLACS: To evaluate the safety and efficacy of femto capsulotomy flap technique in femtosecond laser assisted cataract surgery (FLACS) for dense cataracts and c

Sponsors

Nethradhama superspeciality eye hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cataract grade NO4NC4 or more (according to LOCS III CLASSIFICATION) undergoing FLACS. Subjects are willing and able to understand and sign an informed consent. Subjects are willing and able to attend postoperative examinations per protocol schedule

Exclusion criteria

Exclusion criteria: 1. Cataract grade less than NO4 NC4 2. Chronic uveitis 3. Endothelial cell density (ECD) less than 1500 cells/mm2 4. Pupil dilatation less than 6mm 5. Anterior chamber depth (ACD) equals to or less than VH2 6. Concurrent participation in another drug or device study.

Design outcomes

Primary

MeasureTime frame
UCVA, BCVA, ECD (endothelial cell density)Timepoint: Time Frame: Pre-operative visit, 1 day, 15, 90, and 180 Days Follow-up—

Secondary

MeasureTime frame
1. Coefficient of variation of corneal endothelium 2. Corneal clarity (Grading of oedema)Timepoint: 1. Time Frame: Pre-operative visit, 1 day, 15, 90, and 180 Days Follow-up 2. Time Frame: Post-op day 1, 15, 90, and 180 Days Follow-up—

Countries

India

Contacts

Public ContactDr Sri Ganesh

Nethradhama superspeciality eye hospital

phacomaverick@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026