Impact of pupil size on add power required for intermediate vision with monofocal and monofocal plus intraocular lenses

Impact of pupil size on add power required for intermediate vision with monofocal and monofocal plus intraocular lenses - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097085

Enrollment

150

Registered

2025-11-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: PCS- Health Condition 2: H259- Unspecified age-related cataract

Interventions

Intervention1: Cataract Surgery with Intraocular Lens Implantation: MICS phacoemulsification will be performed under topical anaesthesia alongwith in the bag implantation of a foldable IOL Control Int

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults (40 years or older at the time of participation in the study) with previous implantation of monofocal or monofocal plus IOLs at least 4 months. 2. Subject must be able to understand and sign an IRB/IEC approved Informed Consent form. 3. Subject is willing and able to complete all required experimental visits

Exclusion criteria

Exclusion criteria: 1. Subjects currently participating in another investigational drug or device study 2. History of clinically significant ocular comorbidities that would affect outcome measures based on Investigator expert medical opinion 3. History of corneal or intraocular surgery (except cataract surgery) 4. History of intraocular lasers or any other procedures 5. Clinically significant PCO affecting vision 6. Pregnancy at the time of enrollment 7. History of current ocular or systemic medication that would affect outcome measures based on Investigator expert medical opinion 8. Contraindications to contact lens wear 9. Allergy to Phenylephrine hydrochloride or Tropicamide solution

Design outcomes

Primary

Measure	Time frame
To descriptively compare the mean photopic add power to monocularly resolve 20/32 and 20/20 letters at 66 cm (from spectacle plane) at 100% contrast through a 3 mm pupil in subjects implanted with Clareon Aspheric Monofocal/monofocal toric IOL, Tecnis monofocal/monofocal toric IOL and Tecnis Eyhance / Eyhance toric IOL. To descriptively compare the mean photopic add power to monocularly resolve 20/32 and 20/20 letters at 66 cm (from spectacle plane) at 100% contrast through a 4.50 mm pupil in subjects implanted with Clareon Aspheric Monofocal/monofocal toric IOL, Tecnis monofocal/monofocal toric IOL and Tecnis Eyhance / Eyhance toric IOL. Exploratory Effectiveness:Timepoint:	—

Measure

Time frame

To descriptively compare the mean photopic add power to monocularly resolve 20/32 and 20/20 letters at 66 cm (from spectacle plane) at 100% contrast through a 3 mm pupil in subjects implanted with Clareon Aspheric Monofocal/monofocal toric IOL, Tecnis monofocal/monofocal toric IOL and Tecnis Eyhance / Eyhance toric IOL. To descriptively compare the mean photopic add power to monocularly resolve 20/32 and 20/20 letters at 66 cm (from spectacle plane) at 100% contrast through a 4.50 mm pupil in subjects implanted with Clareon Aspheric Monofocal/monofocal toric IOL, Tecnis monofocal/monofocal toric IOL and Tecnis Eyhance / Eyhance toric IOL. Exploratory Effectiveness:Timepoint:

—

Secondary

Measure	Time frame
Visual acuities at distance intermediate and nearTimepoint:	—

Countries

India

Contacts

Public ContactAbhay R Vasavada

Raghudeep Eye Hospital

icirc@abhayvasavada.com9825700378

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026