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A clinical study to see 1 year safety and efficacy of phakic Intraocular lens with central hole implantation in myopic patients

Prospective evaluation of 1 year changes in anterior chamber dimensions, endothelial cell count and vault size after implantation of phakic IOL with Central Hole

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/022191
Enrollment
50
Registered
2019-11-27
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: H521- Myopia

Interventions

Intervention1: phakic IOL with central hole implantation: Patient will be followed up till 1 year Postoperatively.. Specular microscopy,pentacam and anterior segment OCT will be done to see changes i

Sponsors

Dr Barkha Mehta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age- 18- 30 years Myopia -7.0 D to -23 D with � 5 D of astigmatism at the spectacle plane with emmetropia as target Myopia ranging from > -23.0 D with � 5D of astigmatism at the spectacle plane with a target to reduce the refractive error Anterior chamber depth (ACD) � 2.8 mm A stable refractive history within 0.5 D for 1 year prior to implantation

Exclusion criteria

Exclusion criteria: Patients with age 30 yrs Anterior chamber depth Any history of glaucoma, macular edema , retinal detachment , any retinal surgery Endothelial cell count of less than 2100 Patient with hypermetropia Patient with cataract

Design outcomes

Primary

MeasureTime frame
UCVA, BCVATimepoint: day 1, 1 month , 3 month, 6 month, 1 year—

Secondary

MeasureTime frame
vault size,endothelial cell count, anterior chamber depth and volume ,anterior chamber angle width, position of toric phakic IOLTimepoint: day 1, 1 month, 3 month, 6 month, 1 year—

Countries

India

Contacts

Public ContactDr Barkha Mehta

Centre for sight Hospital ,Safdarjung enclave , New Delhi

hemlatagupta@rediffmail.com9958354550

Outcome results

None listed

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