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Comparison of two gel like substances in terms of immediate rise in eye pressure after insertion of Visian Implantable Collamer Lens

Comparison of IOP spikes with two ophthalmic viscosurgical devices following Visian ICL(V4C model) insertion in the immediate post operative period

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/05/004594
Enrollment
15
Registered
2014-05-13
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: null- Healthy individuals undergoing ICL procedure in both eyes for correction of myopia and myopic astigmatism

Interventions

Intervention1: GROUP A - 2%HPMC: ICL implanataion for correction of myopia and myopic refractive error. Control Intervention1: Group B 1% HYALURONIC ACID: ICL implantation for correction of myopia a

Sponsors

Nethradhama Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of any gender, between the age group of 21 to 45 years, undergoing ICL surgery with V4C (Centraflow) model for correction of Myopic refractive error including myopic astigmatism (of any degree) will be included in the trial. 1.Adequate AC depth ( >2.8 mm from endothelium) 2.Healthy eyes besides myopic refractive error (of any degree amenable to correction with Visian ICL, Centraflow) 3. Stable refraction and corneal conditions within the last 12 months 4.Signed informed consent , willingness to participate in trial and subsequent follow ups

Exclusion criteria

Exclusion criteria: Glaucoma or IOP higher than 24mmHg Posterior segment disorders (e.g. Retinal degenerations , macular pathology, optic nerve atrophy, hereditary retinal disorders) Pseudophakia/ Aphakia Corneal dystrophies / corneal degenerations /Corneal scarring Irregular astigmatism (e.g. Keratoconus, Pallucid Marginal Degeneration etc) Post corneal refractive surgery Moderate to severe dry eye, Severe Contact lens induced ocular allergy Congenital ocular anomalies â?? Aniridia/ Iris coloboma, microcornea, nanophthalmos Amblyopia Pseudoexfoliation Syndrome; Uveitis Prior use of long term antiglaucoma or steroid medications

Design outcomes

Primary

MeasureTime frame
Intraocular pressure with two OVD agents in immediate post op periodTimepoint: 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 15 day post op—

Secondary

MeasureTime frame
ICL position with Anterior Segment OCTTimepoint: 15 days post operative—

Countries

India

Contacts

Public ContactDr Sri Ganesh

Nethradhama Superspeciality Eye Hospital, Bangalore

brar_sheetal@yahoo.co.in9591002092

Outcome results

None listed

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