Treatment of Residual Myopic Refraction After 6 Months on Pseudophakic Patients Using Relex-Smile

Eye Hospital Pristina Kosovo

Status: Invitation-only

Conditions: Myopia; Pseudophakia

Treatments: Procedure: Relex-Smile surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04693663

EHP

Details and patient eligibility

About

The aim of this study is to assess visual and refractive outcomes after laser vision correction (LVC) - ReLex Smile to correct residual myopic refraction after 6 months of pseudophakic (IOL) implantation.

Before SMILE YAG-Laser capsulotomy should be performed on all patients, regardless of posterior capsule ossification, in pseudophakic patients with residual refraction. When the YAG Laser is applied after the SMILE, there will be a diopter change.

Full description

The residual myopic refraction after 6 month on pseudophakic patients using Relex-Smile surgery using VisuMax Femtosecond Laser.The residual myopic refractive power is between -0.75D till -5.50D.The optical zone(lenticule diameter) and cap diameter were 6.5 and 7.5 mm respectively.After dissection of both anterior and posterior planes, the lenticule was extracted through 120 degree superior 3.5mm incision and marked with a sterile marker(Viscot-Medster)

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• residual myopic refraction -0.75d till -5.50D
• complain visual acuity regarding residual myopic refraction

Exclusion criteria

• active anterior segment pathologic features
• previous corneal or anterior segment surgery
• glaucoma
• history of ocular inflammation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

ReLex Smile surgery

Other group

Description:

Procedure/Surgery: Relex Smile The residual myopic refraction on Pseudophakic patients after 6 months using Relex-Smile surgery by VisuMax femtosecond laser. The residual refractive power was between -0.75D till -5.50D.The optical zone (lenticule diameter) and cap diameter were 6.5 and 7.5 mm respectively. After dissection of both anterior and posterior planes, the lenticule was extracted through 120 degree superior 3.5 mm incision and marked with a sterile marker(Viscot-Medster).

Treatment:

Procedure: Relex-Smile surgery