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Study of changes in posterior surface of cornea following a refractive surgical procedure ReLEx SMILE

Posterior corneal curvature changes following ReLEx SMILE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2014/10/005083
Enrollment
60
Registered
2014-10-08
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- Patients with myopia who underwent ReLEx SMILE procedure

Interventions

Intervention1: ReLEx SMILE: Under topical anaesthesia, VisuMax femtosecond laser (Carl Zeiss Meditec AG) was used for the small- incision lenticule extraction. The patient was positioned under the cur

Sponsors

NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Any gender, 21 to 40 years of age •Stable corneal conditions within the last 12 months •Stable refraction since past 12 months ( •Healthy ocular surface with stable tear film •Discontinuation of Soft contact lenses 1 week, and rigid contact lenses 3 weeks prior to surgery

Exclusion criteria

Exclusion criteria: •Age less than 21 or more than 40 years. •Thin corneas (Corneal pachymetry •Steep corneas Kmax >48 D •Keratoconus suspects or frank keratoconus •Mixed astigmatism •Irregular astigmatism (e.g. Keratoconus, Pallucid Marginal Degeneration etc.) •Moderate to severe dry eye (Shirmers1 •Socket / globe /lid anomalies â?? very deep set eyes, nanophthalmos •Severe meibomian gland disease, lid abnormalities •Severe atopy •Contact lens overuse •Severe Contact lens induced ocular allergy •Pregnant and nursing mother •Autoimmune disorders •Pts on systemic medications e.g. Iso retinoic acid, hormonal preparations, OCPs, antidepressants. •ACD (endo) •Cataract or glaucoma •Pseudophakia/ Aphakia •Abnormal endothelial cell count •Irido- corneal angles less than Grade III •Posterior segment disorders (e.g. Retinal degenerations, macular pathology, optic nerve atrophy, or hereditary retinal disorders) •Corneal dystrophies/ corneal degenerations/ Corneal scarring •Congenital ocular anomalies â?? Aniridia, Iris coloboma, microcornea, nanophthalmos •Amblyopia •Pseudoexfoliation Syndrome; Uveitis •Previous intraocular and corneal surgery •Glaucoma or IOP higher than 24mmHg •Prior use of long term antiglaucoma or steroid medications •Other pre-existing processes that permanently limit the best corrected visual acuity to > 0.3 log MAR •Any pathology or condition presenting, according to the investigator opinion, a risk for the patient

Design outcomes

Primary

MeasureTime frame
To compare changes in posterior corneal curvature following ReLEx SMILE in low, moderate and high myopiaTimepoint: 3 months

Secondary

MeasureTime frame
nilTimepoint: nil

Countries

India

Contacts

Public ContactDR SRI GANESH

NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL

utsav_5093@yahoo.com09901903149

Outcome results

None listed

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