Orthoptic Changes Following Photorefractive Keratectomy

NCT ID: NCT01279993

Last Updated: 2011-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-04-30

Brief Summary

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Purpose: To detect orthoptic changes in patients undergoing photorefractive keratectomy (PRK). Method: This interventional case series was performed on 297 eyes of 150 patients who were candidates for PRK. Complete ophthalmic evaluations focusing on orthoptic examinations were performed before and 3 months after PRK. Results: Before PRK, two (1.3%) patients had esotropia that remained unchanged postoperatively. However, 3 (2%) patients had distance exotropia preoperatively which improved after PRK. Of 12 cases (8%) with preoperative exotropia at near, 3 (2%) cases became orthophoric. Six patients (4%) developed postoperative near exotropia. A significant reduction in means of convergence and divergence amplitudes (P\<0.001) and a meaningful increase in mean of near point of convergence (NPC) (P\<0.006) were noticed after PRK. A reduction of ≥10 PD in convergence amplitude and ≥5 PD in divergence amplitude were detected in 10 and 5 patients, respectively. Four patients had an preoperative NPC\>10 cm which was not changed by the surgery. Out of 9 (6%) patients with baseline stereopsis \>60 seconds of arc, 2 (1.33%) cases showed an improvement in stereopsis following PRK. None of the patients complained of postoperative diplopia. Conclusion: Eye deviation in patients undergoing PRK may improve or remain unchanged after operation and postoperative deviations can develop following this surgery. Diminishing of fusional amplitude and increasing of NPC as well as improving of stereopsis may also happen after PRK. Therefore, a preoperative orthoptic examination in patients with any concerning histories and/or motility issues on routine exam is recommended before performing PRK.

Detailed Description

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Conditions

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Orthoptic Changes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Study Groups

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Kerato refractive Surgery

Group Type EXPERIMENTAL

Kerato refractive Surgery

Intervention Type PROCEDURE

This interventional case series was performed on 297 eyes of 150 patients who were candidates for PRK. Complete ophthalmic evaluations focusing on orthoptic examinations were performed before and 3 months after PRK.

Interventions

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Kerato refractive Surgery

This interventional case series was performed on 297 eyes of 150 patients who were candidates for PRK. Complete ophthalmic evaluations focusing on orthoptic examinations were performed before and 3 months after PRK.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\>18 yrs / refractive errors / with consent

Exclusion Criteria

\< 18 / corneal opacity - keratoconus

Dry eye / diabetes / collages vacuolar disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ophthalmic Research center

Principal Investigators

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zhaleh rajavi, Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

Imam Hossein Medical Center

Locations

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Labbafinejad medical center

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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8659

Identifier Type: -

Identifier Source: org_study_id

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