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: study to access laser to posterior capsule in laser assisted cataract surgery patients

A prospective, randomized, pilot, comparative clinical study to assess Primary Posterior Capsulotomy with Femto LDV Z8 in patients undergoing cataract surgery(FLACS). - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085605
Enrollment
40
Registered
2025-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: H259- Unspecified age-related cataract

Interventions

Intervention1: Primary Posterior Capsulotomy with Femto LDV Z8 in patients undergoing cataract surgery(FLACS): During the proposed pilot phase, a group undergoing FLACS with systematic posterior capsu

Sponsors

Nethradhama Super Speciality Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age-related Cataract Best corrected Visual Acuity of not more than 6by 7.5 Nuclear Sclerotic Cataract Lens opacification which can be graded on the LOCS III scale with NC Grade 1 or higher (20) with cc and PSC Patients with eyes which are anatomically suitable to undergo FLACS with the Ziemer Femto LDV Z8

Exclusion criteria

Exclusion criteria: Previous history of ocular pathologies, such as Age-related Macular Degeneration, Diabetic Retinopathy, any type of Glaucoma, Uveitis, Ocular Tumor Previous Ocular Surgery Corneal Opacities such as scars, ulcers, or related to endothelial dystrophy Pupil diameter of less than 6 mm or intraoperative floppy-iris syndrome Issues related to general health condition, such as uncontrolled diabetes, cardiovascular diseases, chronic kidney disease, uncontrolled hypertension Concurrent participation in another clinical study Weak zonules , subluxated Cataractous lens and PPC Operative complications, including posterior capsular tear, zonular dialysis, lens drop in vitreous.

Design outcomes

Primary

MeasureTime frame
provide valuable insights into whether this approach could offer a safer alternative for managing PCO, thereby improving patient outcomes and expanding the preventive and therapeutic options available for cataract surgery patients and to optimize surgical and laser parameters and provide a first evaluation in terms of safety and efficacy.Timepoint: postoperative days 1, 14, and 45 days

Secondary

MeasureTime frame
ascertain occurrence of common complications in Nd:YAG posterior capsulotomy.Timepoint: postoperative days 1, 14, and 45 days

Countries

India

Contacts

Public ContactDrPavithra priyadarshini P R

Nethradhama Super Speciality Eye Hospital

sush.samak@gmail.com9448071800

Outcome results

None listed

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