To study and compare the visual outcomes and stability of two presbyopia correcting toric intraocular lenses

Clinical outcomes following capsulotomy versus capsular bag fixated presbyopia correcting toric intraocular lenses - A prospective comparative study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/074867

Enrollment

120

Registered

2024-10-07

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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: FEMTIS MULTIFOCAL TORIC LENS: FEMTIS M-Plus Toric (Teleon Surgicals BV) is a single piece aspheric multifocal Toric presbyopia correcting intraocular lens made of hydro smart material.

Eligibility

Inclusion criteria

Inclusion criteria: Bilateral Implantation (Second eye surgery within 10 +/- 4 days). Cataractous eyes with no comorbidity. Regular corneal topography and corneal astigmatism. Regular corneal topography and corneal astigmatism from 0.75 D to 4.00 D. Availability, willingness and sufficient cognitive awareness to comply with examination procedures

Exclusion criteria

Exclusion criteria: Active ocular disease in the operative eye, for example, chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma unresponsive to medication, corneal decompensation and corneal endothelial cell insufficiency. Subjects with any systemic disease that could increase operative risk or confound the outcome. Pregnant or lactating or planning a pregnancy at the time of enrolment. Any patient who is taking part in another study involving ocular surgery. Significant irregular corneal astigmatism- Keratoconus/ post refractive surgery/ post LASIK ectasia. Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under Mesopic/scotopic conditions).

Design outcomes

Primary

Measure	Time frame
To analyze and compare prospectively the post-operative visual and refractive outcomes, contrast sensitivity and patient satisfaction following implantation of 2 types of presbyopia correcting toric intra ocular lenses.Timepoint: post op day 1, 1 week, 1 month, 6 months and 12 months post-operative follow-up	—

Secondary

Measure	Time frame
To compare the axial as well as rotational stability of the study IOLs at day 1, 1 week, 1 month, 6 months and 12 months post-operative follow-up.Timepoint: post op day 1, 1 week, 1 month, 6 months and 12 months post-operative follow-up	—

Countries

India

Contacts

Public ContactDr Riya Chopra

Nethradhama Super-speciality Eye hospital

riyachopra1154@gmail.com9780100894

Outcome results

None listed

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