Outcomes of blended vision created by laser using special software in patients having near vision difficulty

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/09/005011
• Date of registration: 11-09-2014
• Prospective Registration: No
• Primary sponsor: Research Foundation Nethradhama Eye Hospital
• Public title: Outcomes of blended vision created by laser using special software in patients having near vision difficulty
• Scientific title: Clinical outcomes and patient satisfaction following Laser Blended Vision for presbyopia correction using MeL 90 platform - LBV
• Date of first enrolment: 01-09-2014
• Target sample size: 50
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10062
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Sheetal Brar
• Affiliation: Nethradhama Superspeciality Eye Hospital

• Name: Dr Sri Ganesh
• Affiliation: Nethradhama Superspeciality Eye Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1.Subjects medically suitable for LASIK,

2. Presbyopic with corrected distant visual acuity(CDVA) no worse than 20/25 in either eye

3. Tolerance of at least -0.75 D anisometropia

4. Myopic patients with spherical equivalent (SE) refraction -8.50 D in both eyes

5. Hyperopic patients with SE upto +5.75 D in both eyes

6. Willing to accept a slight difference in vision between both eyes 8. Willing to use prescription corrective lenses to enhance vision to do precision tasks(reading small prints, needlework)

7. Soft contact lens discontinued for minimum 1 week and Rigid Gas Permeable contact lens discontinued for minimum 3 week

8.Ability to understand and willingness to sign informed consent and participate in follow up visits


Exclusion criteria: 1.Eyes with dense amblyopia with BSCVA < 6/12

2.Evidence of ocular diseases like severe meibomian gland diseases, herpetic keratitis, uvietis, glaucoma.

3.Visually significant cataract, retinal diseases like retinal dystrophies or diabetic retinopathy.

4.Corneal pathologies like corneal dystrophies , keratoconus, H/o corneal trauma or surgery within flap zone

5.Dry eye status-Schirmerâ??s I value less than 10 mm

6.Long term ocular medication like β blockers.

7. Patients on systemic medication likely to affect wound healing like corticosteroids or antimetabolites.

8.H/o immunocompromised state or pregnancy or nursing mothers .

9.Patients with unrealistic expectations.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- healthy individuals in presbyopic age group

Intervention(s)

Intervention1: micromonovision using Mel 90: Dominant eye will be corrected for distance and non dominant eye corrected for near by keeping an anisometropia of -1.50 D, using the Mel-90 Laser platform
Control Intervention1: NIL: NIL

Primary Outcome(s)

improvement in uncorrected distance, intermediate and near visionTimepoint: day 1, day 15,3 months, and 6 months

Secondary Outcome(s)

aberrations, topography, contrast sensitivityTimepoint: day 15, 3 months, 6 months

Secondary ID(s)

2014/22

Source(s) of Monetary Support

Research Foundation, Nethradhama Eye Hospital

Ethics review

Status: Approved
Approval date: 20/08/2014
Contact:

Nethradhama Superspeciality Eye Hospital